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Norethindrone
Activella, Aygestin, Combipatch, Fe, Lupaneta Pack, Nor-qd, Norethin 1/50m, Norinyl, Norlestrin, Norlutate, Ortho-novum, Rhuzdah, Taytulla (norethindrone) is a small molecule pharmaceutical. Norethindrone was first approved as Norlestrin fe 1/50 on 1982-01-01. It is used to treat acne vulgaris, endometrial hyperplasia, endometriosis, hypogonadism, and menorrhagia in the USA. The pharmaceutical is active against progesterone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Nor-qd (generic drugs available since 1987-01-29, discontinued: Aygestin, Micronor, Norlutate, Norlutin)
Combinations
Activella, Combipatch, Lo loestrin fe, Myfembree, Rhuzdah, Taytulla, Tri-norinyl (generic drugs available since 1987-01-29, discontinued: Balziva, Brevicon, Cyclafem, Estrostep, Estrostep fe, Femcon fe, Femhrt, Gencept, Gildess, Lo minastrin fe, Loestrin, Loestrin 21, Lupaneta pack, Microgestin, Minastrin, Modicon, N.e.e., Norcept, Norethin, Norethin 1/50m, Norinyl, Norinyl 1+35, Norinyl 1+50, Norinyl 1+80, Norlestrin, Norlestrin 21, Norquest fe, Nortrel, Ortho-novum, Ovcon, Pirmella)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ACTIVELLAAmneal PharmaceuticalsN-020907 RX1998-11-18
1 products, RLD, RS
COMBIPATCHNoven PharmaceuticalsN-020870 RX1998-08-07
2 products, RLD, RS
Show 1 discontinued
Estradiol
+
Norethindrone acetate
+
Relugolix
Tradename
Company
Number
Date
Products
MYFEMBREEMyovant SciencesN-214846 RX2021-05-26
1 products, RLD, RS
Ethinyl estradiol
+
Ferrous fumarate
+
Norethindrone
Tradename
Company
Number
Date
Products
NORQUEST FEMylanN-018926 DISCN1986-07-18
1 products
Hide discontinued
Ethinyl estradiol
+
Ferrous fumarate
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
NORLESTRIN FE 1/50PfizerN-016766 DISCN1982-01-01
1 products
NORLESTRIN FE 2.5/50PfizerN-016854 DISCN1982-01-01
1 products
Hide discontinued
Ethinyl estradiol
+
Norethindrone
Tradename
Company
Number
Date
Products
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAllerganN-022573 RX2010-12-22
1 products, RLD, RS
TRI-NORINYL 28-DAYDr Reddys LaboratoriesN-018977 RX1984-04-13
1 products, RLD, RS
Show 20 discontinued
Ethinyl estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
LO LOESTRIN FEAllerganN-022501 RX2010-10-21
1 products, RLD, RS
TAYTULLAAllerganN-204426 RX2013-04-19
1 products, RLD, RS
Show 13 discontinued
Leuprolide acetate
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
LUPANETA PACKAbbVieN-203696 DISCN2012-12-14
2 products, RLD
Hide discontinued
Mestranol
+
Norethindrone
Tradename
Company
Number
Date
Products
NORINYL 1+50 21-DAYAllerganN-013625 DISCN1982-01-01
1 products
NORINYLAllerganN-013625 DISCN1982-01-01
1 products
NORINYL 1+50 28-DAYAllerganN-016659 DISCN1982-01-01
1 products, RLD
NORINYL 1+80 21-DAYG.D. SearleN-016724 DISCN1982-01-01
1 products
NORINYL 1+80 28-DAYG.D. SearleN-016725 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/50 28Johnson & JohnsonN-016709 DISCN1982-01-01
1 products
ORTHO-NOVUM 10-21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/50 21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 2-21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/80 21Johnson & JohnsonN-016715 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/80 28Johnson & JohnsonN-016715 DISCN1982-01-01
1 products
Hide discontinued
Norethindrone
Tradename
Company
Number
Date
Products
NOR-QDTevaN-017060 RX1982-01-01
1 products, RLD, RS
Show 2 discontinued
Norethindrone acetate
Tradename
Company
Number
Date
Products
AYGESTINDuramed PharmaceuticalsN-018405 DISCN1982-04-21
1 products, RLD
NORLUTATEPfizerN-012184 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
activellaNew Drug Application2021-08-26
alyacen 7/7/7ANDA2023-06-07
amabelzANDA2021-12-01
aranelleANDA2021-12-16
aurovela 24 feANDA2023-06-14
aygestinANDA2015-10-31
balzivaANDA2023-06-07
blisovi fe 1/20 ANDA2023-03-31
briellynANDA2017-05-25
camilaANDA2018-05-29
Show 36 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
endometrial hyperplasia—D004714N85.0
endometriosisEFO_0001065D004715N80
hypogonadismHP_0000815D007006E23.0
menorrhagiaHP_0000132D008595N92.0
Agency Specific
FDA
EMA
Expiration
Code
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES
2026-01-27M-289
2025-12-18NCE
2025-08-05I-898
2024-05-26NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
110335512037-09-29U-3129
93468222024-02-17U-3129
73009352024-01-28DP
80582802024-01-28DP
Ethinyl Estradiol / Norethindrone Acetate, Lo Loestrin Fe, Apil
77049842029-02-02U-1, U-1090
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA05: Norethisterone and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB04: Norethisterone and ethinylestradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC01: Norethisterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DC: Estren derivatives, sex hormones and modulators of the genital system
— G03DC02: Norethisterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA01: Norethisterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB05: Norethisterone and estrogen
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CC: Anti-gonadotropin-releasing hormones
— H01CC54: Relugolix, estradiol and norethisterone
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9——2—13
ContraceptionD003267112——3
Hiv infectionsD015658EFO_0000764B202—1——3
PregnancyD011247EFO_0002950Z33.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients——4———4
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ebola hemorrhagic feverD019142EFO_0007243A98.41————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chikungunya virusD002646————11
Dengue virusD003716————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNORETHINDRONE
INNnorethisterone
Description
Norethisterone is a 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen. It has a role as a synthetic oral contraceptive and a progestin. It is a 17beta-hydroxy steroid, a terminal acetylenic compound, a tertiary alcohol and a 3-oxo-Delta(4) steroid. It derives from a hydride of an estrane.
Classification
Small molecule
Drug classProgestogen (medication); Progestin
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21C
Identifiers
PDB1SQN
CAS-ID68-22-4
RxCUI7514
ChEMBL IDCHEMBL1162
ChEBI ID7627
PubChem CID6230
DrugBankDB00717
UNII IDT18F433X4S (ChemIDplus, GSRS)
Target
Agency Approved
PGR
PGR
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
5241
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Q9UPF7
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Loestrin - Allergan
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Loestrin - Warner Chilcott
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Loestrin - AbbVie
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Myfembree - Myovant Sciences
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,563 documents
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Safety
Black-box Warning
Black-box warning for: Activella, Amabelz, Aurovela 24 fe, Blisovi fe 1/20 , Combipatch (estradiol/norethindrone acetate transdermal system), Cyclafem 1/35, Cyonanz, Dasetta 1/35, Femhrt, Finzala, Fyavolv, Gemmily, Hailey 1.5/30, Junel fe, Kaitlib fe , Lo loestrin fe, Merzee, Mibelas 24 fe , Microgestin 1.5/30 , Minastrin 24 fe, Myfembree, Nexesta fe, Nylia 1/35, Oriahnn, Taytulla, Tri-legest fe, Wera
Adverse Events
Top Adverse Reactions
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17 adverse events reported
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