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norethindrone acetate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1963 | 51-98-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.01 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.63 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK | 20 | |||
| kinase-selectivity-class | EIF2AK3,GRK2,MAP2K6 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 30, 1973 | FDA | WARNER CHILCOTT LLC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic adenoma | 214.83 | 15.97 | 37 | 8446 | 402 | 90619562 |
| Vaginal haemorrhage | 197.93 | 15.97 | 83 | 8400 | 31188 | 90588776 |
| Heavy menstrual bleeding | 148.59 | 15.97 | 60 | 8423 | 20470 | 90599494 |
| Endometriosis | 138.20 | 15.97 | 42 | 8441 | 6206 | 90613758 |
| Pelvic pain | 108.08 | 15.97 | 44 | 8439 | 15313 | 90604651 |
| Hot flush | 102.98 | 15.97 | 66 | 8417 | 59422 | 90560542 |
| Prostatic disorder | 75.08 | 15.97 | 11 | 8472 | 36 | 90619928 |
| Intermenstrual bleeding | 63.43 | 15.97 | 26 | 8457 | 9197 | 90610767 |
| Aplastic anaemia | 60.52 | 15.97 | 28 | 8455 | 13241 | 90606723 |
| Borderline serous tumour of ovary | 53.09 | 15.97 | 7 | 8476 | 7 | 90619957 |
| Metaplasia | 48.66 | 15.97 | 11 | 8472 | 510 | 90619454 |
| Purpura | 45.90 | 15.97 | 24 | 8459 | 14754 | 90605210 |
| Haemorrhage | 44.86 | 15.97 | 43 | 8440 | 69326 | 90550638 |
| Mood swings | 40.90 | 15.97 | 25 | 8458 | 20677 | 90599287 |
| Menstruation irregular | 39.87 | 15.97 | 18 | 8465 | 8042 | 90611922 |
| Dysmenorrhoea | 38.48 | 15.97 | 15 | 8468 | 4657 | 90615307 |
| Adnexal torsion | 37.79 | 15.97 | 9 | 8474 | 525 | 90619439 |
| Ovarian cyst | 37.02 | 15.97 | 22 | 8461 | 17296 | 90602668 |
| Abdominal pain | 32.67 | 15.97 | 96 | 8387 | 395625 | 90224339 |
| Nasal mucosal discolouration | 29.68 | 15.97 | 5 | 8478 | 47 | 90619917 |
| Rash maculo-papular | 25.75 | 15.97 | 25 | 8458 | 40908 | 90579056 |
| Menstrual disorder | 25.05 | 15.97 | 12 | 8471 | 6126 | 90613838 |
| Pulmonary embolism | 24.58 | 15.97 | 44 | 8439 | 130776 | 90489188 |
| Dermatitis atopic | 24.20 | 15.97 | 19 | 8464 | 23453 | 90596511 |
| Arthropathy | 24.03 | 15.97 | 3 | 8480 | 366239 | 90253725 |
| Rash erythematous | 23.95 | 15.97 | 30 | 8453 | 65074 | 90554890 |
| Migraine | 23.76 | 15.97 | 54 | 8429 | 190338 | 90429626 |
| Acne | 22.97 | 15.97 | 20 | 8463 | 28487 | 90591477 |
| Abnormal uterine bleeding | 22.18 | 15.97 | 8 | 8475 | 2004 | 90617960 |
| Transfusion | 22.13 | 15.97 | 16 | 8467 | 17472 | 90602492 |
| Surgery | 22.05 | 15.97 | 24 | 8459 | 44863 | 90575101 |
| Product administration interrupted | 21.94 | 15.97 | 14 | 8469 | 12478 | 90607486 |
| Abnormal withdrawal bleeding | 21.72 | 15.97 | 4 | 8479 | 65 | 90619899 |
| Post viral fatigue syndrome | 21.60 | 15.97 | 5 | 8478 | 258 | 90619706 |
| Uterine leiomyoma | 21.15 | 15.97 | 13 | 8470 | 10851 | 90609113 |
| Hepatic rupture | 20.84 | 15.97 | 4 | 8479 | 82 | 90619882 |
| Superior sagittal sinus thrombosis | 20.33 | 15.97 | 6 | 8477 | 800 | 90619164 |
| Haemoglobin decreased | 20.28 | 15.97 | 46 | 8437 | 161910 | 90458054 |
| Uterine spasm | 20.11 | 15.97 | 6 | 8477 | 831 | 90619133 |
| Contraindicated product administered | 20.10 | 15.97 | 3 | 8480 | 320136 | 90299828 |
| Uterine pain | 19.74 | 15.97 | 5 | 8478 | 377 | 90619587 |
| Abdominal distension | 19.69 | 15.97 | 40 | 8443 | 130561 | 90489403 |
| Melaena | 19.57 | 15.97 | 20 | 8463 | 34777 | 90585187 |
| Blood iron decreased | 19.52 | 15.97 | 15 | 8468 | 17944 | 90602020 |
| Coronary artery dissection | 19.34 | 15.97 | 6 | 8477 | 948 | 90619016 |
| Irritability | 19.16 | 15.97 | 20 | 8463 | 35642 | 90584322 |
| Peliosis hepatis | 19.07 | 15.97 | 4 | 8479 | 130 | 90619834 |
| Menopausal symptoms | 18.88 | 15.97 | 8 | 8475 | 3070 | 90616894 |
| Depression | 18.49 | 15.97 | 66 | 8417 | 300535 | 90319429 |
| Pregnancy on oral contraceptive | 18.42 | 15.97 | 6 | 8477 | 1109 | 90618855 |
| Haemorrhagic tumour necrosis | 18.24 | 15.97 | 3 | 8480 | 24 | 90619940 |
| Intracranial pressure increased | 18.17 | 15.97 | 10 | 8473 | 6801 | 90613163 |
| Mood altered | 17.94 | 15.97 | 14 | 8469 | 17130 | 90602834 |
| Exposure to allergen | 17.93 | 15.97 | 5 | 8478 | 545 | 90619419 |
| Tympanic membrane perforation | 17.31 | 15.97 | 7 | 8476 | 2390 | 90617574 |
| Crying | 16.76 | 15.97 | 16 | 8467 | 25629 | 90594335 |
| Treatment failure | 16.64 | 15.97 | 4 | 8479 | 303924 | 90316040 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic adenoma | 231.09 | 18.03 | 37 | 6236 | 430 | 110582596 |
| Vaginal haemorrhage | 200.64 | 18.03 | 69 | 6204 | 25005 | 110558021 |
| Metaplasia | 132.43 | 18.03 | 24 | 6249 | 603 | 110582423 |
| Heavy menstrual bleeding | 119.17 | 18.03 | 42 | 6231 | 16323 | 110566703 |
| Endometriosis | 95.49 | 18.03 | 26 | 6247 | 4308 | 110578718 |
| Prostatic disorder | 94.14 | 18.03 | 23 | 6250 | 2486 | 110580540 |
| Pelvic pain | 72.54 | 18.03 | 29 | 6244 | 15913 | 110567113 |
| Hot flush | 63.38 | 18.03 | 42 | 6231 | 65994 | 110517032 |
| Borderline serous tumour of ovary | 55.66 | 18.03 | 7 | 6266 | 9 | 110583017 |
| Intermenstrual bleeding | 55.10 | 18.03 | 19 | 6254 | 6915 | 110576111 |
| Aplastic anaemia | 54.75 | 18.03 | 27 | 6246 | 24281 | 110558745 |
| Adnexal torsion | 44.10 | 18.03 | 9 | 6264 | 427 | 110582599 |
| Purpura | 43.07 | 18.03 | 23 | 6250 | 24365 | 110558661 |
| Ovarian cyst | 35.98 | 18.03 | 17 | 6256 | 13913 | 110569113 |
| Menstruation irregular | 35.15 | 18.03 | 13 | 6260 | 5784 | 110577242 |
| Dysmenorrhoea | 33.04 | 18.03 | 11 | 6262 | 3599 | 110579427 |
| Haemorrhage | 30.80 | 18.03 | 34 | 6239 | 106658 | 110476368 |
| Mood swings | 30.70 | 18.03 | 18 | 6255 | 22794 | 110560232 |
| Borderline ovarian tumour | 30.63 | 18.03 | 5 | 6268 | 66 | 110582960 |
| Nasal mucosal discolouration | 29.97 | 18.03 | 5 | 6268 | 76 | 110582950 |
| Haemorrhagic tumour necrosis | 25.26 | 18.03 | 4 | 6269 | 43 | 110582983 |
| Rash erythematous | 25.22 | 18.03 | 27 | 6246 | 81805 | 110501221 |
| Uterine leiomyoma | 24.80 | 18.03 | 11 | 6262 | 7789 | 110575237 |
| Abnormal withdrawal bleeding | 24.56 | 18.03 | 4 | 6269 | 52 | 110582974 |
| Transfusion | 23.94 | 18.03 | 16 | 6257 | 25456 | 110557570 |
| Post viral fatigue syndrome | 23.67 | 18.03 | 5 | 6268 | 281 | 110582745 |
| Blood iron decreased | 22.85 | 18.03 | 14 | 6259 | 19200 | 110563826 |
| Genital haemorrhage | 22.33 | 18.03 | 10 | 6263 | 7242 | 110575784 |
| Migraine | 22.19 | 18.03 | 37 | 6236 | 171615 | 110411411 |
| Abdominal pain | 21.57 | 18.03 | 71 | 6202 | 512918 | 110070108 |
| Superior sagittal sinus thrombosis | 21.18 | 18.03 | 6 | 6267 | 1147 | 110581879 |
| Hepatic rupture | 20.60 | 18.03 | 4 | 6269 | 147 | 110582879 |
| Death | 20.59 | 18.03 | 7 | 6266 | 698862 | 109884164 |
| Rash maculo-papular | 20.29 | 18.03 | 23 | 6250 | 74199 | 110508827 |
| Exposure to allergen | 20.28 | 18.03 | 5 | 6268 | 560 | 110582466 |
| Throat tightness | 20.01 | 18.03 | 16 | 6257 | 33473 | 110549553 |
| Acne | 20.00 | 18.03 | 16 | 6257 | 33504 | 110549522 |
| Abnormal uterine bleeding | 19.84 | 18.03 | 6 | 6267 | 1441 | 110581585 |
| Peliosis hepatis | 19.53 | 18.03 | 4 | 6269 | 193 | 110582833 |
| Off label use | 19.33 | 18.03 | 148 | 6125 | 1500037 | 109082989 |
| Dermatitis atopic | 19.22 | 18.03 | 14 | 6259 | 25527 | 110557499 |
| Haemoglobin decreased | 19.10 | 18.03 | 43 | 6230 | 248684 | 110334342 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA CS | M0447349 | Progesterone Congeners |
| FDA Chemical/Ingredient | N0000011301 | Progesterone Congeners |
| MeSH PA | D000080066 | Contraceptive Agents, Hormonal |
| MeSH PA | D003271 | Contraceptive Agents, Female |
| MeSH PA | D012102 | Reproductive Control Agents |
| MeSH PA | D003278 | Contraceptives, Oral, Hormonal |
| MeSH PA | D003280 | Contraceptives, Oral, Synthetic |
| FDA EPC | N0000175602 | Progestin |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:49326 | synthetic oral contraceptive |
| CHEBI has role | CHEBI:59826 | progestin |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Contraception | indication | 13197004 | |
| Dysfunctional uterine bleeding | indication | 19155002 | |
| Secondary physiologic amenorrhea | indication | 86030004 | |
| Acne vulgaris | indication | 88616000 | |
| Uterine fibroids | indication | 95315005 | DOID:13223 |
| Endometriosis | indication | 129103003 | |
| Amenorrhea | off-label use | 14302001 | DOID:13938 |
| Female hypogonadism syndrome | off-label use | 16041008 | |
| Polycystic ovaries | off-label use | 69878008 | |
| Dysmenorrhea | off-label use | 266599000 | |
| Abnormal uterine bleeding unrelated to menstrual cycle | off-label use | 312984006 | |
| Menorrhagia | off-label use | 386692008 | |
| Heart valve disorder | contraindication | 368009 | DOID:4079 |
| Hypercholesterolemia | contraindication | 13644009 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Depressive disorder | contraindication | 35489007 | |
| Migraine | contraindication | 37796009 | DOID:6364 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Body fluid retention | contraindication | 43498006 | |
| Thrombosis of retinal vein | contraindication | 46085004 | |
| Chronic heart failure | contraindication | 48447003 | |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Hyperlipidemia | contraindication | 55822004 | DOID:1168 |
| Benign mammary dysplasia | contraindication | 57993004 | |
| Obstructive hyperbilirubinemia | contraindication | 59848001 | |
| Thrombophlebitis | contraindication | 64156001 | DOID:3875 |
| Intermenstrual bleeding - irregular | contraindication | 64996003 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Malignant neoplasm of liver | contraindication | 93870000 | DOID:3571 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Angina pectoris | contraindication | 194828000 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Cerebrovascular accident | contraindication | 230690007 | |
| Pulmonary thromboembolism | contraindication | 233935004 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Cholestasis of pregnancy | contraindication | 235888006 | |
| Endometrial carcinoma | contraindication | 254878006 | DOID:2871 |
| Pregnancy, function | contraindication | 289908002 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Functional visual loss | contraindication | 313165001 | |
| Malignant tumor of cervix | contraindication | 363354003 | DOID:4362 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Estrogen receptor positive tumor | contraindication | 416053008 | |
| Porphyria | contraindication | 418470004 | |
| Optic disc edema | contraindication | 423341008 | DOID:146 |
| Hypertensive urgency | contraindication | 443482000 | |
| Carcinoma of female breast | contraindication | 447782002 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Major Surgery with Prolonged Post-Operative Immobilization | contraindication | ||
| Nonspecific Abnormal Papanicolaou Smear of Cervix | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.01MG,0.01MG;1MG,N/A | LO LOESTRIN FE | APIL | N022501 | Oct. 21, 2010 | RX | TABLET | ORAL | 7704984 | Feb. 2, 2029 | LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION |
| 0.01MG,0.01MG,N/A;1MG,N/A,N/A | LO MINASTRIN FE | APIL | N204654 | July 24, 2013 | DISCN | TABLET, CHEWABLE, TABLET | ORAL | 7704984 | Feb. 2, 2029 | PREVENTION OF PREGNANCY |
| 1MG;0.5MG;40MG | MYFEMBREE | SUMITOMO PHARMA AM | N214846 | May 26, 2021 | RX | TABLET | ORAL | 11033551 | Sept. 29, 2037 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
| 1MG;0.5MG;40MG | MYFEMBREE | SUMITOMO PHARMA AM | N214846 | May 26, 2021 | RX | TABLET | ORAL | 11957684 | Sept. 29, 2037 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
| 1MG;0.5MG;40MG | MYFEMBREE | SUMITOMO PHARMA AM | N214846 | May 26, 2021 | RX | TABLET | ORAL | 11793812 | May 3, 2038 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1MG;0.5MG;40MG | MYFEMBREE | SUMITOMO PHARMA AM | N214846 | May 26, 2021 | RX | TABLET | ORAL | Jan. 27, 2026 | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 |
| 0.02MG;1MG | FEMLYV | MILLICENT MFG PR | N218718 | July 22, 2024 | RX | TABLET, ORALLY DISINTEGRATING | ORAL | July 22, 2027 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Progesterone receptor | Nuclear hormone receptor | AGONIST | ED50 | 11.26 | WOMBAT-PK | CHEMBL | |||
| Glucocorticoid receptor | Nuclear hormone receptor | Ki | 6.53 | DRUG MATRIX | |||||
| Estrogen receptor | Nuclear hormone receptor | Ki | 6.64 | CHEMBL | |||||
| Androgen receptor | Nuclear hormone receptor | IC50 | 7.12 | WOMBAT-PK | |||||
| Cytochrome P450 2C19 | Enzyme | IC50 | 6.10 | DRUG MATRIX | |||||
| Sex hormone-binding globulin | Secreted | Kd | 7.97 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 5.62 | CHEMBL | |||||
| Androgen receptor | Transcription factor | Ki | 7.15 | DRUG MATRIX | |||||
| Progesterone receptor | Transcription factor | Ki | 8.44 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| D00953 | KEGG_DRUG |
| 4018495 | VANDF |
| 4018496 | VANDF |
| C0068980 | UMLSCUI |
| CHEBI:7628 | CHEBI |
| CHEMBL1201146 | ChEMBL_ID |
| D000077563 | MESH_DESCRIPTOR_UI |
| 5832 | PUBCHEM_CID |
| 9S44LIC7OJ | UNII |
| 215496 | RXNORM |
| 182290 | MMSL |
| 2712 | MMSL |
| 41718 | MMSL |
| 5187 | MMSL |
| 5188 | MMSL |
| d00555 | MMSL |
| 001298 | NDDF |
| 001299 | NDDF |
| 001326 | NDDF |
| 005925 | NDDF |
| 126102009 | SNOMEDCT_US |
| 126104005 | SNOMEDCT_US |
| 63758001 | SNOMEDCT_US |
| C0028356 | UMLSCUI |
| DB00717 | DRUGBANK_ID |
| 6230 | PUBCHEM_CID |
| 687 | INN_ID |
| D009640 | MESH_DESCRIPTOR_UI |
| CHEBI:7627 | CHEBI |
| 9S44LIC7OJ | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Jinteli | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-3122 | TABLET | 1 mg | ORAL | ANDA | 29 sections |
| Mimvey | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-5455 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 30 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7274 | TABLET | 1.50 mg | ORAL | ANDA | 21 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7280 | TABLET | 1 mg | ORAL | ANDA | 22 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-0211 | TABLET | 5 mg | ORAL | ANDA | 20 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9025 | TABLET | 1 mg | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9027 | TABLET | 1.50 mg | ORAL | ANDA | 15 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-650 | TABLET | 5 mg | ORAL | ANDA | 12 sections |
| Norethindrone Acetate and Ethinyl Estradiol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-6782 | TABLET | 1 mg | ORAL | ANDA | 16 sections |
| Estradiol / Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-8003 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 32 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-8004 | TABLET | 0.10 mg | ORAL | ANDA | 27 sections |
| Norethindrone acetate | Human Prescription Drug Label | 1 | 50742-267 | TABLET | 5 mg | ORAL | ANDA | 20 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50742-657 | TABLET | 0.50 mg | ORAL | ANDA | 27 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50742-658 | TABLET | 0.10 mg | ORAL | ANDA | 27 sections |
| Loestrin21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51285-127 | TABLET | 1.50 mg | ORAL | ANDA | 15 sections |
| Loestrin21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51285-131 | TABLET | 1 mg | ORAL | ANDA | 15 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-599 | TABLET | 5 mg | ORAL | ANDA | 20 sections |
| Estradiol / Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51991-474 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 33 sections |
| Estradiol / Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51991-623 | TABLET, FILM COATED | 0.10 mg | ORAL | ANDA | 33 sections |
| MICROGESTIN 1/20 | HUMAN PRESCRIPTION DRUG LABEL | 2 | 53002-1549 | TABLET | 1 mg | ORAL | NDA AUTHORIZED GENERIC | 21 sections |
| Estradiol / Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-4677 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 25 sections |
| femhrt | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-4679 | TABLET | 1 mg | ORAL | NDA | 20 sections |
| Microgestin | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-6213 | TABLET | 1 mg | ORAL | ANDA | 24 sections |
| JINTELI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-6251 | TABLET | 1 mg | ORAL | ANDA | 25 sections |
| Junel 1.5/30 | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-6272 | TABLET | 1.50 mg | ORAL | ANDA | 23 sections |
| Etyqa | Human Prescription Drug Label | 2 | 59651-424 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 29 sections |
| Etyqa | Human Prescription Drug Label | 2 | 59651-425 | TABLET, FILM COATED | 0.10 mg | ORAL | ANDA | 29 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60687-921 | TABLET | 5 mg | ORAL | ANDA | 21 sections |
| Activella | HUMAN PRESCRIPTION DRUG LABEL | 2 | 60846-231 | TABLET, FILM COATED | 0.10 mg | ORAL | NDA | 28 sections |
| Activella | HUMAN PRESCRIPTION DRUG LABEL | 2 | 60846-232 | TABLET, FILM COATED | 0.50 mg | ORAL | NDA | 28 sections |