norethindrone acetate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 |
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 |
|---|---|---|---|---|---|---|
| Vaginal haemorrhage | 203.11 | 17.21 | 85 | 6813 | 27402 | 63454722 |
| Heavy menstrual bleeding | 151.81 | 17.21 | 61 | 6837 | 17712 | 63464412 |
| Endometriosis | 147.34 | 17.21 | 44 | 6854 | 5276 | 63476848 |
| Pelvic pain | 110.61 | 17.21 | 45 | 6853 | 13474 | 63468650 |
| Hot flush | 90.91 | 17.21 | 61 | 6837 | 51098 | 63431026 |
| Hepatic adenoma | 87.15 | 17.21 | 17 | 6881 | 326 | 63481798 |
| Intermenstrual bleeding | 73.91 | 17.21 | 29 | 6869 | 7897 | 63474227 |
| Prostatic disorder | 69.06 | 17.21 | 11 | 6887 | 59 | 63482065 |
| Borderline serous tumour of ovary | 49.91 | 17.21 | 7 | 6891 | 12 | 63482112 |
| Purpura | 48.44 | 17.21 | 24 | 6874 | 11361 | 63470763 |
| Metaplasia | 46.97 | 17.21 | 11 | 6887 | 513 | 63481611 |
| Mood swings | 42.94 | 17.21 | 26 | 6872 | 18222 | 63463902 |
| Aplastic anaemia | 40.20 | 17.21 | 20 | 6878 | 9549 | 63472575 |
| Adnexal torsion | 37.91 | 17.21 | 9 | 6889 | 445 | 63481679 |
| Abdominal pain | 37.64 | 17.21 | 92 | 6806 | 293364 | 63188760 |
| Menstruation irregular | 33.51 | 17.21 | 16 | 6882 | 6988 | 63475136 |
| Dysmenorrhoea | 31.71 | 17.21 | 13 | 6885 | 3960 | 63478164 |
| Haemorrhage | 31.60 | 17.21 | 36 | 6862 | 60986 | 63421138 |
| Depression | 29.99 | 17.21 | 66 | 6832 | 196426 | 63285698 |
| Rash erythematous | 28.94 | 17.21 | 29 | 6869 | 42481 | 63439643 |
| Rash maculo-papular | 27.90 | 17.21 | 25 | 6873 | 31871 | 63450253 |
| Ovarian cyst | 25.89 | 17.21 | 18 | 6880 | 15927 | 63466197 |
| Menstrual disorder | 25.00 | 17.21 | 12 | 6886 | 5301 | 63476823 |
| Uterine leiomyoma | 23.97 | 17.21 | 14 | 6884 | 9184 | 63472940 |
| Rectal haemorrhage | 23.83 | 17.21 | 28 | 6870 | 49002 | 63433122 |
| Migraine | 23.39 | 17.21 | 41 | 6857 | 103305 | 63378819 |
| Pulmonary embolism | 22.26 | 17.21 | 43 | 6855 | 116641 | 63365483 |
| Anxiety | 21.54 | 17.21 | 62 | 6836 | 217479 | 63264645 |
| Hepatic rupture | 21.19 | 17.21 | 4 | 6894 | 64 | 63482060 |
| Peliosis hepatis | 20.64 | 17.21 | 4 | 6894 | 74 | 63482050 |
| Mood altered | 20.17 | 17.21 | 15 | 6883 | 14728 | 63467396 |
| Post viral fatigue syndrome | 19.93 | 17.21 | 5 | 6893 | 312 | 63481812 |
| Transfusion | 19.75 | 17.21 | 15 | 6883 | 15202 | 63466922 |
| Exposure to allergen | 19.73 | 17.21 | 5 | 6893 | 325 | 63481799 |
| Superior sagittal sinus thrombosis | 19.56 | 17.21 | 6 | 6892 | 785 | 63481339 |
| Menopausal symptoms | 19.46 | 17.21 | 8 | 6890 | 2453 | 63479671 |
| Melaena | 19.36 | 17.21 | 20 | 6878 | 30345 | 63451779 |
| Intracranial pressure increased | 19.26 | 17.21 | 10 | 6888 | 5217 | 63476907 |
| Pregnancy on oral contraceptive | 17.97 | 17.21 | 6 | 6892 | 1031 | 63481093 |
| Acne | 17.93 | 17.21 | 17 | 6881 | 23276 | 63458848 |
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 |
|---|---|---|---|---|---|---|
| Vaginal haemorrhage | 206.59 | 20.40 | 69 | 4700 | 21748 | 79717871 |
| Metaplasia | 133.80 | 20.40 | 24 | 4745 | 538 | 79739081 |
| Heavy menstrual bleeding | 119.52 | 20.40 | 41 | 4728 | 13970 | 79725649 |
| Endometriosis | 103.24 | 20.40 | 27 | 4742 | 3641 | 79735978 |
| Prostatic disorder | 96.37 | 20.40 | 23 | 4746 | 2137 | 79737482 |
| Hepatic adenoma | 77.53 | 20.40 | 14 | 4755 | 326 | 79739293 |
| Pelvic pain | 76.00 | 20.40 | 29 | 4740 | 13352 | 79726267 |
| Hot flush | 58.48 | 20.40 | 38 | 4731 | 54839 | 79684780 |
| Borderline serous tumour of ovary | 54.09 | 20.40 | 7 | 4762 | 12 | 79739607 |
| Purpura | 46.77 | 20.40 | 23 | 4746 | 19504 | 79720115 |
| Adnexal torsion | 44.79 | 20.40 | 9 | 4760 | 374 | 79739245 |
| Intermenstrual bleeding | 37.94 | 20.40 | 14 | 4755 | 5870 | 79733749 |
| Aplastic anaemia | 36.75 | 20.40 | 19 | 4750 | 17886 | 79721733 |
| Borderline ovarian tumour | 36.45 | 20.40 | 5 | 4764 | 16 | 79739603 |
| Mood swings | 32.13 | 20.40 | 18 | 4751 | 19862 | 79719757 |
| Rash erythematous | 27.98 | 20.40 | 25 | 4744 | 57744 | 79681875 |
| Dysmenorrhoea | 26.29 | 20.40 | 9 | 4760 | 3036 | 79736583 |
| Menstruation irregular | 25.34 | 20.40 | 10 | 4759 | 5026 | 79734593 |
| Ovarian cyst | 24.74 | 20.40 | 13 | 4756 | 12642 | 79726977 |
| Rash maculo-papular | 24.68 | 20.40 | 23 | 4746 | 56055 | 79683564 |
| Abdominal pain | 24.15 | 20.40 | 64 | 4705 | 389505 | 79350114 |
| Transfusion | 23.27 | 20.40 | 15 | 4754 | 21315 | 79718304 |
| Genital haemorrhage | 23.24 | 20.40 | 10 | 4759 | 6245 | 79733374 |
| Uterine leiomyoma | 22.96 | 20.40 | 10 | 4759 | 6433 | 79733186 |
| Exposure to allergen | 22.53 | 20.40 | 5 | 4764 | 336 | 79739283 |
| Post viral fatigue syndrome | 22.42 | 20.40 | 5 | 4764 | 344 | 79739275 |
| Blood iron decreased | 22.32 | 20.40 | 13 | 4756 | 15421 | 79724198 |
| Rectal haemorrhage | 22.13 | 20.40 | 25 | 4744 | 76275 | 79663344 |
| Haemorrhage | 21.71 | 20.40 | 27 | 4742 | 91091 | 79648528 |
| Hepatic rupture | 21.65 | 20.40 | 4 | 4765 | 106 | 79739513 |
| Superior sagittal sinus thrombosis | 21.35 | 20.40 | 6 | 4763 | 1057 | 79738562 |
| Migraine | 20.96 | 20.40 | 26 | 4743 | 87467 | 79652152 |
| Anxiety | 20.94 | 20.40 | 46 | 4723 | 248466 | 79491153 |
| Peliosis hepatis | 20.60 | 20.40 | 4 | 4765 | 139 | 79739480 |
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 | D003270 | Contraceptive Agents |
| MeSH PA | D003271 | Contraceptive Agents, Female |
| MeSH PA | D000080066 | Contraceptive Agents, Hormonal |
| MeSH PA | D012102 | Reproductive Control Agents |
| MeSH PA | D003278 | Contraceptives, Oral, Hormonal |
| MeSH PA | D003280 | Contraceptives, Oral, Synthetic |
| CHEBI has role | CHEBI:49326 | synthetic oral contraceptives |
| CHEBI has role | CHEBI:59826 | progestins |
| FDA EPC | N0000175602 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | 9346822 | Feb. 17, 2024 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
| 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 | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | 11033551 | Sept. 29, 2037 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
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 | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | May 26, 2024 | NEW PRODUCT |
| 1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | Aug. 5, 2025 | FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
| 1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | Dec. 18, 2025 | NEW CHEMICAL ENTITY |
| 1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | Jan. 27, 2026 | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 |
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 | |||
| Sodium-dependent serotonin transporter | Transporter | Ki | 5.62 | 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 | |||||
| Progesterone receptor | Transcription factor | Ki | 8.44 | DRUG MATRIX | |||||
| Androgen receptor | Transcription factor | Ki | 7.15 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| D00953 | KEGG_DRUG |
| 4018495 | VANDF |
| 4018496 | VANDF |
| C0068980 | UMLSCUI |
| CHEBI:7628 | CHEBI |
| CHEBI:7627 | CHEBI |
| CHEMBL1201146 | ChEMBL_ID |
| CHEMBL1162 | ChEMBL_ID |
| D000077563 | MESH_DESCRIPTOR_UI |
| 5832 | PUBCHEM_CID |
| 9S44LIC7OJ | UNII |
| DB00717 | DRUGBANK_ID |
| 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 |
| 687 | INN_ID |
| 6230 | PUBCHEM_CID |
| D009640 | MESH_DESCRIPTOR_UI |
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 | 15 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7274 | TABLET | 1.50 mg | ORAL | ANDA | 15 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7280 | TABLET | 1 mg | ORAL | ANDA | 15 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-7291 | TABLET | 5 mg | ORAL | ANDA | 12 sections |
| ESTRADIOL AND NORETHINDRONE ACETATE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7294 | TABLET | 0.10 mg | ORAL | ANDA | 26 sections |
| ESTRADIOL AND NORETHINDRONE ACETATE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7295 | TABLET | 0.50 mg | ORAL | ANDA | 26 sections |
| femhrt | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0430-0145 | TABLET | 0.50 mg | ORAL | NDA | 33 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 | 0555-9025 | TABLET | 1 mg | ORAL | ANDA | 15 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 |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9027 | TABLET | 1.50 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 | 16571-658 | TABLET | 5 mg | ORAL | ANDA | 19 sections |
| Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-650 | TABLET | 5 mg | ORAL | ANDA | 12 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 | 29 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50742-657 | TABLET | 0.50 mg | ORAL | ANDA | 29 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50742-658 | TABLET | 0.10 mg | ORAL | ANDA | 29 sections |
| Estradiol and Norethindrone Acetate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50742-658 | TABLET | 0.10 mg | ORAL | ANDA | 29 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 | 51285-127 | TABLET | 1.50 mg | ORAL | ANDA | 15 sections |
| Loestrin21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51285-131 | TABLET | 1 mg | ORAL | ANDA | 15 sections |
| Loestrin21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51285-131 | TABLET | 1 mg | ORAL | ANDA | 15 sections |
| Aygestin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51285-424 | TABLET | 5 mg | ORAL | ANDA | 20 sections |
| MICROGESTIN 1/20 | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51862-007 | TABLET | 1 mg | ORAL | NDA authorized generic | 21 sections |
| MICROGESTIN 1/20 | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51862-007 | TABLET | 1 mg | ORAL | NDA authorized generic | 21 sections |