norethisterone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroids, progestogens | 1962 | 68-22-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2.50 | mg | P |
| 5 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.01 mg/mL | Bocci G, Oprea TI, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 2 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.02 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 64 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 21, 1962 | FDA | ORTHO MCNEIL PHARM |
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 | 124.73 | 17.99 | 59 | 6311 | 27428 | 63455224 |
| Hepatic adenoma | 101.02 | 17.99 | 19 | 6351 | 324 | 63482328 |
| Prostatic disorder | 69.94 | 17.99 | 11 | 6359 | 59 | 63482593 |
| Heavy menstrual bleeding | 65.16 | 17.99 | 33 | 6337 | 17740 | 63464912 |
| Endometriosis | 56.69 | 17.99 | 21 | 6349 | 5299 | 63477353 |
| Superior sagittal sinus thrombosis | 48.31 | 17.99 | 12 | 6358 | 779 | 63481873 |
| Aplastic anaemia | 47.89 | 17.99 | 22 | 6348 | 9547 | 63473105 |
| Metaplasia | 47.84 | 17.99 | 11 | 6359 | 513 | 63482139 |
| Purpura | 47.24 | 17.99 | 23 | 6347 | 11362 | 63471290 |
| Pelvic pain | 46.35 | 17.99 | 24 | 6346 | 13495 | 63469157 |
| Intermenstrual bleeding | 45.32 | 17.99 | 20 | 6350 | 7906 | 63474746 |
| Cerebral venous sinus thrombosis | 41.62 | 17.99 | 13 | 6357 | 1959 | 63480693 |
| Pregnancy on oral contraceptive | 40.38 | 17.99 | 11 | 6359 | 1026 | 63481626 |
| Transfusion | 38.25 | 17.99 | 22 | 6348 | 15195 | 63467457 |
| Exposure to allergen | 35.94 | 17.99 | 8 | 6362 | 322 | 63482330 |
| Ovarian atrophy | 32.44 | 17.99 | 6 | 6364 | 93 | 63482559 |
| Drug-induced liver injury | 32.28 | 17.99 | 29 | 6341 | 40193 | 63442459 |
| Uterine perforation | 31.72 | 17.99 | 15 | 6355 | 6948 | 63475704 |
| Rash erythematous | 30.90 | 17.99 | 29 | 6341 | 42481 | 63440171 |
| Hereditary angioedema | 30.54 | 17.99 | 15 | 6355 | 7547 | 63475105 |
| Rash maculo-papular | 29.63 | 17.99 | 25 | 6345 | 31871 | 63450781 |
| Genital burning sensation | 25.96 | 17.99 | 6 | 6364 | 286 | 63482366 |
| Product dose omission issue | 25.78 | 17.99 | 66 | 6304 | 234247 | 63248405 |
| Febrile neutropenia | 24.26 | 17.99 | 43 | 6327 | 118406 | 63364246 |
| Haemorrhage | 23.84 | 17.99 | 30 | 6340 | 60992 | 63421660 |
| Blood iron decreased | 23.62 | 17.99 | 16 | 6354 | 14705 | 63467947 |
| Vaginal ulceration | 23.57 | 17.99 | 6 | 6364 | 430 | 63482222 |
| Hot flush | 23.00 | 17.99 | 27 | 6343 | 51132 | 63431520 |
| Rectal haemorrhage | 22.24 | 17.99 | 26 | 6344 | 49004 | 63433648 |
| Hepatic rupture | 21.50 | 17.99 | 4 | 6366 | 64 | 63482588 |
| Lip exfoliation | 21.34 | 17.99 | 6 | 6364 | 629 | 63482023 |
| Acne | 21.10 | 17.99 | 18 | 6352 | 23275 | 63459377 |
| Peliosis hepatis | 20.96 | 17.99 | 4 | 6366 | 74 | 63482578 |
| Dilatation intrahepatic duct acquired | 20.88 | 17.99 | 6 | 6364 | 680 | 63481972 |
| Melaena | 20.70 | 17.99 | 20 | 6350 | 30345 | 63452307 |
| Menstruation irregular | 19.97 | 17.99 | 11 | 6359 | 6993 | 63475659 |
| Mast cell activation syndrome | 19.79 | 17.99 | 6 | 6364 | 819 | 63481833 |
| Device dislocation | 19.57 | 17.99 | 18 | 6352 | 25687 | 63456965 |
| Haemoglobin decreased | 19.21 | 17.99 | 44 | 6326 | 145441 | 63337211 |
| Depression | 18.23 | 17.99 | 52 | 6318 | 196440 | 63286212 |
| Abortion spontaneous | 18.11 | 17.99 | 23 | 6347 | 47172 | 63435480 |
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 | 139.29 | 19.84 | 52 | 4900 | 21765 | 79717671 |
| Metaplasia | 126.38 | 19.84 | 23 | 4929 | 539 | 79738897 |
| Prostatic disorder | 95.51 | 19.84 | 23 | 4929 | 2137 | 79737299 |
| Hepatic adenoma | 90.13 | 19.84 | 16 | 4936 | 324 | 79739112 |
| Heavy menstrual bleeding | 63.26 | 19.84 | 26 | 4926 | 13985 | 79725451 |
| Superior sagittal sinus thrombosis | 50.52 | 19.84 | 12 | 4940 | 1051 | 79738385 |
| Purpura | 43.02 | 19.84 | 22 | 4930 | 19505 | 79719931 |
| Pregnancy on oral contraceptive | 42.56 | 19.84 | 10 | 4942 | 835 | 79738601 |
| Aplastic anaemia | 41.86 | 19.84 | 21 | 4931 | 17884 | 79721552 |
| Cerebral venous sinus thrombosis | 41.38 | 19.84 | 12 | 4940 | 2279 | 79737157 |
| Pelvic pain | 41.33 | 19.84 | 19 | 4933 | 13362 | 79726074 |
| Transfusion | 41.19 | 19.84 | 22 | 4930 | 21308 | 79718128 |
| Intermenstrual bleeding | 41.11 | 19.84 | 15 | 4937 | 5869 | 79733567 |
| Exposure to allergen | 39.50 | 19.84 | 8 | 4944 | 333 | 79739103 |
| Drug-induced liver injury | 37.89 | 19.84 | 32 | 4920 | 66085 | 79673351 |
| Uterine perforation | 36.49 | 19.84 | 14 | 4938 | 6289 | 79733147 |
| Endometriosis | 35.81 | 19.84 | 12 | 4940 | 3656 | 79735780 |
| Ovarian atrophy | 35.56 | 19.84 | 6 | 4946 | 89 | 79739347 |
| Vaginal ulceration | 29.11 | 19.84 | 6 | 4946 | 273 | 79739163 |
| Genital burning sensation | 28.14 | 19.84 | 6 | 4946 | 322 | 79739114 |
| Blood iron decreased | 27.24 | 19.84 | 15 | 4937 | 15419 | 79724017 |
| Rash erythematous | 27.17 | 19.84 | 25 | 4927 | 57744 | 79681692 |
| Rash maculo-papular | 23.94 | 19.84 | 23 | 4929 | 56055 | 79683381 |
| Lip exfoliation | 23.89 | 19.84 | 6 | 4946 | 662 | 79738774 |
| Ovarian failure | 23.82 | 19.84 | 6 | 4946 | 670 | 79738766 |
| Dilatation intrahepatic duct acquired | 23.30 | 19.84 | 6 | 4946 | 732 | 79738704 |
| Complication of device insertion | 22.74 | 19.84 | 10 | 4942 | 6340 | 79733096 |
| Device dislocation | 22.35 | 19.84 | 16 | 4936 | 25954 | 79713482 |
| Maternal exposure during pregnancy | 21.76 | 19.84 | 34 | 4918 | 136504 | 79602932 |
| Acne | 21.69 | 19.84 | 16 | 4936 | 27174 | 79712262 |
| Hepatic rupture | 21.50 | 19.84 | 4 | 4948 | 106 | 79739330 |
| Peliosis hepatis | 20.45 | 19.84 | 4 | 4948 | 139 | 79739297 |
| Migraine | 20.18 | 19.84 | 26 | 4926 | 87467 | 79651969 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G03AA05 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AB04 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AC01 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens |
| ATC | G03DC02 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS Estren derivatives |
| ATC | G03FA01 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, fixed combinations |
| ATC | G03FB05 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, sequential preparations |
| ATC | H01CC53 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones |
| ATC | H01CC54 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones |
| 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 | D003278 | Contraceptives, Oral, Hormonal |
| MeSH PA | D003280 | Contraceptives, Oral, Synthetic |
| MeSH PA | D012102 | Reproductive Control Agents |
| 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 | |
| Female hypogonadism syndrome | indication | 16041008 | |
| Dysfunctional uterine bleeding | indication | 19155002 | |
| Atrophic vaginitis | indication | 52441000 | |
| Primary ovarian failure | indication | 65846009 | |
| Secondary physiologic amenorrhea | indication | 86030004 | |
| Acne vulgaris | indication | 88616000 | |
| Postmenopausal osteoporosis | indication | 102447009 | |
| Vasomotor symptoms associated with climacteric disturbance | indication | 123756000 | |
| Endometriosis | indication | 129103003 | |
| Menopausal flushing | indication | 198436008 | |
| Atrophic vulva | indication | 248861000 | DOID:14275 |
| Menorrhagia | indication | 386692008 | |
| Controlled ovarian stimulation | indication | 732970000 | |
| Vasomotor symptoms associated with ovarian deficiency symptoms | indication | ||
| Amenorrhea | off-label use | 14302001 | DOID:13938 |
| Polycystic ovaries | off-label use | 69878008 | |
| Dysmenorrhea | off-label use | 266599000 | |
| Abnormal uterine bleeding unrelated to menstrual cycle | off-label use | 312984006 | |
| Heart valve disorder | contraindication | 368009 | DOID:4079 |
| Hyperlipoproteinemia | contraindication | 3744001 | DOID:1168 |
| Hypocalcemia | contraindication | 5291005 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Depressive disorder | contraindication | 35489007 | |
| Chloasma | contraindication | 36209000 | |
| Migraine | contraindication | 37796009 | DOID:6364 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Body fluid retention | contraindication | 43498006 | |
| Thrombosis of retinal vein | contraindication | 46085004 | |
| Humoral hypercalcemia of malignancy | contraindication | 47709007 | |
| Chronic heart failure | contraindication | 48447003 | |
| Dementia | contraindication | 52448006 | |
| Hepatic porphyria | contraindication | 55056006 | DOID:3133 |
| 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 |
| Breast lump | contraindication | 89164003 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Malignant neoplasm of liver | contraindication | 93870000 | DOID:3571 |
| Uterine leiomyoma | contraindication | 95315005 | DOID:13223 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Mammography abnormal | contraindication | 168750009 | |
| Angina pectoris | contraindication | 194828000 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Cerebrovascular accident | contraindication | 230690007 | |
| Pulmonary thromboembolism | contraindication | 233935004 | |
| Thrombophilia | contraindication | 234467004 | DOID:2452 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Cholestasis of pregnancy | contraindication | 235888006 | |
| Endometrial carcinoma | contraindication | 254878006 | DOID:2871 |
| Chorea | contraindication | 271700006 | |
| Pregnancy, function | contraindication | 289908002 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Functional visual loss | contraindication | 313165001 | |
| Malignant tumor of cervix | contraindication | 363354003 | DOID:4362 |
| Malignant tumor of ovary | contraindication | 363443007 | DOID:2394 |
| 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 |
| Family history of malignant neoplasm of breast | contraindication | 429740004 | |
| 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)
None
Orange Book exclusivity data (new drug applications)
None
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 | 6.71 | DRUG MATRIX | |||||
| Estrogen receptor | Nuclear hormone receptor | Ki | 6.64 | DRUG MATRIX | |||||
| Androgen receptor | Nuclear hormone receptor | IC50 | 7.12 | WOMBAT-PK | |||||
| Sex hormone-binding globulin | Secreted | Kd | 7.97 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 5.62 | DRUG MATRIX | |||||
| Androgen receptor | Transcription factor | IC50 | 6.92 | CHEMBL | |||||
| Progesterone receptor | Transcription factor | Ki | 8.91 | DRUG MATRIX | |||||
| Estrogen receptor | Transcription factor | Kd | 9.20 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4018496 | VUID |
| N0000146818 | NUI |
| D00182 | KEGG_DRUG |
| 4018496 | VANDF |
| C0028356 | UMLSCUI |
| CHEBI:7627 | CHEBI |
| CHEMBL1162 | ChEMBL_ID |
| DB00717 | DRUGBANK_ID |
| 2880 | IUPHAR_LIGAND_ID |
| 6230 | PUBCHEM_CID |
| 7514 | RXNORM |
| 182290 | MMSL |
| 5187 | MMSL |
| d00555 | MMSL |
| 001298 | NDDF |
| 001326 | NDDF |
| 126102009 | SNOMEDCT_US |
| 63758001 | SNOMEDCT_US |
| D009640 | MESH_DESCRIPTOR_UI |
| NDR | PDB_CHEM_ID |
| 687 | INN_ID |
| T18F433X4S | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Norethindrone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-7272 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Norethindrone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-7272 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Norethindrone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-7272 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| NORETHINDRONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-7292 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Nortrel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9009 | TABLET | 1 mg | ORAL | ANDA | 21 sections |
| Nortrel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9009 | TABLET | 1 mg | ORAL | ANDA | 21 sections |
| NORETHINDRONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-6161 | TABLET | 0.35 mg | ORAL | ANDA | 13 sections |
| LYZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50102-100 | TABLET | 0.35 mg | ORAL | ANDA | 13 sections |
| Tulana | Human Prescription Drug Label | 1 | 50102-200 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Lyleq | Human Prescription Drug Label | 1 | 50102-300 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Lyleq | Human Prescription Drug Label | 1 | 50102-300 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Ortho Micronor | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-194 | TABLET | 0.35 mg | ORAL | NDA | 24 sections |
| NORLYROC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51660-127 | TABLET, FILM COATED | 0.35 mg | ORAL | ANDA | 12 sections |
| CAMILA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-884 | TABLET | 0.35 mg | ORAL | ANDA | 25 sections |
| ERRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-886 | TABLET | 0.35 mg | ORAL | ANDA | 26 sections |
| ERRIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-886 | TABLET | 0.35 mg | ORAL | ANDA | 26 sections |
| Nora BE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52544-629 | TABLET | 0.35 mg | ORAL | NDA authorized generic | 19 sections |
| Nora BE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52544-629 | TABLET | 0.35 mg | ORAL | NDA authorized generic | 19 sections |
| Nora BE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52544-629 | TABLET | 0.35 mg | ORAL | NDA authorized generic | 19 sections |
| Jolivette | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52544-892 | TABLET | 0.35 mg | ORAL | NDA | 27 sections |
| Lyleq | Human Prescription Drug Label | 1 | 53002-1793 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Tulana | Human Prescription Drug Label | 1 | 53002-2687 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| MICRONOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4369 | TABLET | 0.35 mg | ORAL | NDA | 14 sections |
| Camila | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4814 | TABLET | 0.35 mg | ORAL | ANDA | 15 sections |
| NORETHINDRONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57297-876 | TABLET | 0.35 mg | ORAL | ANDA | 13 sections |
| Jencycla | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57297-877 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| Emzahh | Human Prescription Drug Label | 1 | 59651-136 | TABLET | 0.35 mg | ORAL | ANDA | 21 sections |
| Norethindrone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63187-748 | TABLET | 0.35 mg | ORAL | ANDA | 24 sections |
| Incassia | Human Prescription Drug Label | 1 | 65862-925 | TABLET | 0.35 mg | ORAL | ANDA | 14 sections |
| AMABELZ | HUMAN PRESCRIPTION DRUG LABEL | 2 | 68180-829 | TABLET | 0.10 mg | ORAL | ANDA | 30 sections |