norethisterone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
steroids, progestogens 1962 68-22-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • norethindrone
  • norethisteron
  • norethisterone
  • norethynodrone
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.
  • Molecular weight: 298.43
  • Formula: C20H26O2
  • CLOGP: 2.79
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -4.65
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.50 mg P
5 mg O

ADMET properties:

PropertyValueReference
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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 64 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.257 Moderate 0.73
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.381 Moderate 0.73
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 72.946 10^-6 cm/s Moderate 0.73
dh-clint Dog hepatocyte intrinsic clearance 28.184 uL/min/10^6 cells Moderate 0.73
dppb Dog plasma protein binding (% unbound) 6.610 % Moderate 0.73
fcs-ppb Fetal calf serum protein binding (% unbound) 9.780 % Moderate 0.73
herg hERG pIC50 4.843 pIC50 Moderate 0.73
hh-clint Human hepatocyte intrinsic clearance 3.750 uL/min/10^6 cells Moderate 0.73
hlm-clint Human liver microsomal intrinsic clearance 21.827 uL/min/mg protein Moderate 0.73
hppb Human plasma protein binding (% unbound) 4.690 % Moderate 0.73
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 17
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.197 Moderate 0.73
mh-clint Mouse hepatocyte intrinsic clearance 69.663 Moderate 0.73
mppb Mouse plasma protein binding (% unbound) 6.650 Moderate 0.73
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.373 Moderate 0.73
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 7.880 % Moderate 0.73
rh-clint Rat hepatocyte intrinsic clearance 55.081 uL/min/10^6 cells Moderate 0.73
rh-fuinc Rat hepatocyte fraction unbound in incubation 33.440 % Moderate 0.73
rppb Rat plasma protein binding (% unbound) 5.880 % Moderate 0.73
solubility-dd Solubility at pH 7.4 in DMSO 44.771 uM Moderate 0.73

Approvals:

DateAgencyCompanyOrphan
May 21, 1962 FDA ORTHO MCNEIL PHARM

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic adenoma 210.27 17 36 7938 403 90620070
Vaginal haemorrhage 118.70 17 57 7917 31214 90589259
Prostatic disorder 75.76 17 11 7963 36 90620437
Aplastic anaemia 68.61 17 30 7944 13239 90607234
Heavy menstrual bleeding 64.74 17 33 7941 20497 90599976
Intermenstrual bleeding 61.54 17 25 7949 9198 90611275
Endometriosis 56.08 17 21 7953 6227 90614246
Superior sagittal sinus thrombosis 49.65 17 12 7962 794 90619679
Metaplasia 49.34 17 11 7963 510 90619963
Pelvic pain 46.43 17 24 7950 15333 90605140
Cerebral venous sinus thrombosis 45.08 17 14 7960 2362 90618111
Purpura 44.41 17 23 7951 14755 90605718
Pregnancy on oral contraceptive 41.02 17 11 7963 1104 90619369
Transfusion 40.77 17 23 7951 17465 90603008
Product dose omission issue 36.81 17 80 7894 291607 90328866
Complication of device insertion 33.55 17 17 7957 10419 90610054
Ovarian atrophy 33.22 17 6 7968 93 90620380
Febrile neutropenia 33.19 17 54 7920 158295 90462178
Exposure to allergen 32.92 17 8 7966 542 90619931
Uterine perforation 32.43 17 15 7959 7539 90612934
Haemorrhage 30.55 17 34 7940 69335 90551138
Nasal mucosal discolouration 29.99 17 5 7969 47 90620426
Hot flush 29.42 17 31 7943 59457 90561016
Rash maculo-papular 27.07 17 25 7949 40908 90579565
Hereditary angioedema 26.49 17 14 7960 9351 90611122
Device dislocation 26.38 17 22 7952 31460 90589013
Menstruation irregular 25.53 17 13 7961 8047 90612426
Rash erythematous 25.44 17 30 7944 65074 90555399
Genital burning sensation 25.32 17 6 7968 365 90620108
Blood iron decreased 24.98 17 17 7957 17942 90602531
Mucosal inflammation 24.95 17 28 7946 57597 90562876
Vaginal ulceration 24.14 17 6 7968 446 90620027
Acne 24.05 17 20 7954 28487 90591986
Throat tightness 23.46 17 20 7954 29464 90591009
Pulmonary embolism 21.39 17 40 7934 130780 90489693
Hepatic rupture 21.09 17 4 7970 82 90620391
Dilatation intrahepatic duct acquired 20.99 17 6 7968 762 90619711
Lip exfoliation 20.97 17 6 7968 764 90619709
Ovarian cyst 20.84 17 15 7959 17303 90603170
Melaena 20.62 17 20 7954 34777 90585696
Ovarian failure 20.31 17 7 7967 1636 90618837
Product administration interrupted 20.22 17 13 7961 12479 90607994
Haemoglobin decreased 19.91 17 44 7930 161912 90458561
Peliosis hepatis 19.32 17 4 7970 130 90620343
Drug-induced liver injury 19.18 17 31 7943 90287 90530186
Dermatitis atopic 18.84 17 16 7958 23456 90597017
Haemorrhagic tumour necrosis 18.43 17 3 7971 24 90620449
Abortion spontaneous 18.03 17 23 7951 54033 90566440
Headache 17.70 17 133 7841 862613 89757860
Systemic lupus erythematosus 17.63 17 5 7969 361891 90258582
Migraine 17.27 17 46 7928 190346 90430127
Treatment failure 17.21 17 3 7971 303925 90316548

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic adenoma 222.80 18.02 36 6422 431 110582410
Vaginal haemorrhage 131.73 18.02 51 6407 25023 110557818
Metaplasia 125.26 18.02 23 6435 604 110582237
Prostatic disorder 93.48 18.02 23 6435 2486 110580355
Intermenstrual bleeding 62.36 18.02 21 6437 6913 110575928
Heavy menstrual bleeding 60.89 18.02 26 6432 16339 110566502
Aplastic anaemia 59.97 18.02 29 6429 24279 110558562
Superior sagittal sinus thrombosis 50.28 18.02 12 6446 1141 110581700
Cerebral venous sinus thrombosis 43.63 18.02 13 6445 2882 110579959
Complication of device insertion 42.95 18.02 17 6441 8821 110574020
Pregnancy on oral contraceptive 42.24 18.02 10 6448 918 110581923
Transfusion 41.51 18.02 23 6435 25449 110557392
Purpura 39.68 18.02 22 6436 24366 110558475
Pelvic pain 39.26 18.02 19 6439 15923 110566918
Uterine perforation 36.21 18.02 14 6444 6826 110576015
Exposure to allergen 35.97 18.02 8 6450 557 110582284
Ovarian atrophy 35.93 18.02 6 6452 89 110582752
Endometriosis 34.57 18.02 12 6446 4322 110578519
Nasal mucosal discolouration 29.82 18.02 5 6453 76 110582765
Vaginal ulceration 29.14 18.02 6 6452 289 110582552
Blood iron decreased 27.66 18.02 16 6442 19198 110563643
Genital burning sensation 27.18 18.02 6 6452 403 110582438
Drug-induced liver injury 26.75 18.02 34 6424 120033 110462808
Ovarian failure 26.74 18.02 7 6451 969 110581872
Throat tightness 26.18 18.02 19 6439 33470 110549371
Haemorrhagic tumour necrosis 25.14 18.02 4 6454 43 110582798
Device dislocation 24.81 18.02 18 6440 31686 110551155
Rash erythematous 24.57 18.02 27 6431 81805 110501036
Acne 23.92 18.02 18 6440 33502 110549339
Lip exfoliation 23.33 18.02 6 6452 774 110582067
Dilatation intrahepatic duct acquired 22.87 18.02 6 6452 837 110582004
Product dose omission issue 20.84 18.02 53 6405 321729 110261112
Device expulsion 20.74 18.02 16 6442 30875 110551966
Hepatic rupture 20.48 18.02 4 6454 147 110582694
Medical device pain 19.82 18.02 6 6452 1404 110581437
Rash maculo-papular 19.75 18.02 23 6435 74199 110508642
Escherichia urinary tract infection 19.47 18.02 12 6446 16150 110566691
Peliosis hepatis 19.42 18.02 4 6454 193 110582648
Haemorrhage 18.86 18.02 27 6431 106665 110476176
Migraine 18.84 18.02 35 6423 171617 110411224
Administration site rash 18.79 18.02 3 6455 33 110582808
Headache 18.69 18.02 101 6357 882276 109700565
Ovarian cyst 18.47 18.02 11 6447 13919 110568922
Toxicity to various agents 18.40 18.02 3 6455 480552 110102289
Death 18.28 18.02 9 6449 698860 109883981
Haemoglobin decreased 18.26 18.02 43 6415 248684 110334157

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 D000080066 Contraceptive Agents, Hormonal
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D003278 Contraceptives, Oral, Hormonal
MeSH PA D003280 Contraceptives, Oral, Synthetic
MeSH PA D012102 Reproductive Control Agents
FDA EPC N0000175602 Progestin
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:49326 synthetic oral contraceptive
CHEBI has role CHEBI:59826 progestin

Related Drugs by ATC class:

G03AA Progestogens and estrogens, fixed combinations 17 drugs
G03AB Progestogens and estrogens, sequential preparations 10 drugs
G03AC Progestogens 9 drugs
G03DC Estren derivatives 5 drugs
G03FA Progestogens and estrogens, fixed combinations 15 drugs
G03FB Progestogens and estrogens, sequential preparations 10 drugs
H01CC Anti-gonadotropin-releasing hormones 6 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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
Nonspecific Abnormal Papanicolaou Smear of Cervix contraindication
Major Surgery with Prolonged Post-Operative Immobilization contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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:

IDSource
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
T18F433X4S INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NORETHINDRONE HUMAN PRESCRIPTION DRUG LABEL 1 0378-7292 TABLET 0.35 mg ORAL ANDA 14 sections
NORETHINDRONE HUMAN PRESCRIPTION DRUG LABEL 1 0378-7292 TABLET 0.35 mg ORAL ANDA 14 sections
Nora BE HUMAN PRESCRIPTION DRUG LABEL 1 0480-3475 TABLET 0.35 mg ORAL NDA authorized generic 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
Lyleq Human Prescription Drug Label 1 50102-300 TABLET 0.35 mg ORAL ANDA 14 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
Lyleq Human Prescription Drug Label 1 53002-1793 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
Emzahh Human Prescription Drug Label 1 59651-136 TABLET 0.35 mg ORAL ANDA 21 sections
Norethindrone HUMAN PRESCRIPTION DRUG LABEL 1 60505-4900 TABLET 0.35 mg ORAL ANDA 19 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
NORETHINDRONE HUMAN PRESCRIPTION DRUG LABEL 1 68180-876 TABLET 0.35 mg ORAL ANDA 13 sections
Jencycla HUMAN PRESCRIPTION DRUG LABEL 1 68180-877 TABLET 0.35 mg ORAL ANDA 14 sections
HEATHER HUMAN PRESCRIPTION DRUG LABEL 1 68462-303 TABLET 0.35 mg ORAL ANDA 23 sections
Norethindrone HUMAN PRESCRIPTION DRUG LABEL 1 68462-305 TABLET 0.35 mg ORAL ANDA 24 sections
Orquidea HUMAN PRESCRIPTION DRUG LABEL 1 70700-316 TABLET 0.35 mg ORAL ANDA 14 sections
MELEYA HUMAN PRESCRIPTION DRUG LABEL 1 70700-317 TABLET 0.35 mg ORAL ANDA 14 sections
ERRIN HUMAN PRESCRIPTION DRUG LABEL 1 71205-526 TABLET 0.35 mg ORAL ANDA 24 sections
Norethindrone HUMAN PRESCRIPTION DRUG LABEL 1 72789-439 TABLET 0.35 mg ORAL ANDA 14 sections
CAMILA HUMAN PRESCRIPTION DRUG LABEL 1 75907-074 TABLET 0.35 mg ORAL ANDA 25 sections
ERRIN HUMAN PRESCRIPTION DRUG LABEL 1 75907-075 TABLET 0.35 mg ORAL ANDA 26 sections
Norethindrone HUMAN PRESCRIPTION DRUG LABEL 1 76413-118 TABLET 0.35 mg ORAL ANDA 14 sections
Affodel HUMAN PRESCRIPTION DRUG LABEL 1 79929-015 TABLET 0.35 mg ORAL ANDA 19 sections
NORETHINDRONE HUMAN PRESCRIPTION DRUG LABEL 1 82804-175 TABLET 0.35 mg ORAL ANDA 13 sections