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AboutPricing
Drug ReportsNorgestrel
Norgestrel
Cryselle, Elinest, Low-ogestrel, Opill, Turqoz (norgestrel) is a small molecule pharmaceutical. Norgestrel was first approved as Lo/ovral on 1982-01-01. The pharmaceutical is active against progesterone receptor.
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FDA approval date
EMA approval date
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Last update post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Opill
Combinations
Cryselle, Elinest, Low-ogestrel, Turqoz (discontinued: Lo/ovral, Low-ogestrel, Norgestrel ethinyl estradiol, Ogestrel, Ovral)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Norgestrel
Tradename
Company
Number
Date
Products
OPILLHRA PharmaN-017031 OTC1982-01-01
1 products, RLD, RS
Ethinyl estradiol
+
Norgestrel
Tradename
Company
Number
Date
Products
LO/OVRALCadence PharmaceuticalsN-017612 DISCN1982-01-01
1 products, RLD
OVRALWyethN-016672 DISCN1982-01-01
1 products
LO/OVRAL-28WyethN-017802 DISCN1982-01-01
1 products, RLD
OVRAL-28WyethN-016806 DISCN1982-01-01
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
cryselleANDA2024-05-07
elinestANDA2023-01-31
low-ogestrelANDA2024-10-10
norgestimate and ethinyl estradiolANDA2024-10-02
opillNew Drug Application2024-06-03
previfemANDA2016-12-02
sprintecANDA2024-08-14
tri-lo-sprintecANDA2023-02-01
tri-sprintecANDA2024-10-18
turqozANDA2024-12-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
hot flashes—D019584—
hypogonadismHP_0000044D007006E23.0
premature menopauseHP_0008209D008594E28.31
Agency Specific
FDA
EMA
Expiration
Code
NORGESTREL, OPILL, LABORATOIRE HRA
2026-07-13RTO
Patent Expiration
No data
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
— G03AA06: Norgestrel and ethinylestradiol
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA10: Norgestrel and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB01: Norgestrel and estrogen
HCPCS
Code
Description
J7296
Levonorgestrel-releasing intrauterine contraceptive system, (kyleena), 19.5 mg
J7297
Levonorgestrel-releasing intrauterine contraceptive system (liletta), 52 mg
J7298
Levonorgestrel-releasing intrauterine contraceptive system (mirena), 52 mg
J7301
Levonorgestrel-releasing intrauterine contraceptive system (skyla), 13.5 mg
J7306
Levonorgestrel (contraceptive) implant system, including implants and supplies
S4981
Insertion of levonorgestrel-releasing intrauterine system
Clinical
No data
Drug
General
Drug common nameNorgestrel
INNnorgestrel
Description
Norgestrel is a progestin which is used in birth control pills sold under the brand name Ovral in combination with the estrogen ethinylestradiol and Opill by itself. It is also used in menopausal hormone therapy. It is taken by mouth.
Classification
Small molecule
Drug classestrogens; progestins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C#CC1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21CC
Identifiers
PDB—
CAS-ID6533-00-2
RxCUI—
ChEMBL IDCHEMBL2107797
ChEBI ID—
PubChem CID16051930
DrugBankDB00506
UNII ID3J8Q1747Z2 (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
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Norgestrel
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Norgestrel
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
No data
Safety
Black-box Warning
Black-box warning for: Cryselle, Elinest, Low-ogestrel, Norgestimate and ethinyl estradiol, Previfem, Sprintec, Tri-lo-sprintec, Tri-sprintec, Turqoz
Adverse Events
0 adverse events reported
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