Norgestrel
Cryselle, Elinest, Low-ogestrel, Opill, Prefest, Previfem, Sprintec, Tri-sprintec, 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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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Opill
CombinationsCryselle, 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 |
|---|---|---|---|---|
| OPILL | HRA Pharma | N-017031 OTC | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cryselle | ANDA | 2024-05-07 |
| elinest | ANDA | 2023-01-31 |
| low-ogestrel | ANDA | 2025-07-28 |
| norgestimate and ethinyl estradiol | ANDA | 2025-04-08 |
| opill | New Drug Application | 2025-08-29 |
| previfem | ANDA | 2016-12-02 |
| sprintec | ANDA | 2025-09-24 |
| tri-lo-sprintec | ANDA | 2023-02-01 |
| tri-sprintec | ANDA | 2025-10-01 |
| turqoz | ANDA | 2025-05-15 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NORGESTREL, OPILL, LABORATOIRE HRA | |||
| 2026-07-13 | RTO | ||
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
Clinical Trials
864 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 197 | 3 | 2 | 4 | 2 | 207 |
| Contraception | D003267 | — | — | 11 | 12 | 17 | 19 | 18 | 76 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 25 | 15 | 4 | 7 | 49 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 18 | 17 | 1 | 2 | 31 |
| Infections | D007239 | EFO_0000544 | — | 6 | 2 | 12 | 5 | 5 | 30 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 4 | 11 | 5 | 8 | 28 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 2 | 2 | 1 | 17 | 3 | 24 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 8 | 11 | 3 | 5 | 21 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 8 | 2 | 1 | 1 | 4 | 16 |
| Communicable diseases | D003141 | — | — | — | 1 | 9 | 5 | 1 | 16 |
Show 84 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratitis | D007634 | — | H16 | — | 1 | 7 | — | 2 | 9 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 2 | 1 | 5 | — | — | 7 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 4 | 1 | — | 2 | 6 |
| Community-acquired infections | D017714 | — | — | — | 2 | 4 | — | — | 6 |
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 5 | 4 | — | — | 5 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | 3 | 1 | — | 2 | 5 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | 1 | 1 | 1 | — | 3 | 5 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 1 | 2 | — | 1 | 4 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 3 | — | 1 | 4 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 1 | 3 | — | — | 4 |
Show 90 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 14 | 1 | — | — | — | 15 |
| Neoplasms | D009369 | — | C80 | 5 | 1 | — | — | 1 | 7 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 1 | — | — | — | 4 |
| Thrombosis | D013927 | — | — | — | 1 | — | — | 2 | 3 |
| Metrorrhagia | D008796 | — | N92.1 | — | 2 | — | — | 1 | 3 |
| Pharmacological phenomena | D000069437 | — | — | 2 | 1 | — | — | — | 3 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | 1 | — | — | — | 2 |
| Amenorrhea | D000568 | — | N91.2 | — | 1 | — | — | 1 | 2 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 2 | — | — | — | 2 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 8 | — | — | — | 2 | 10 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 5 | — | — | — | 3 | 8 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 7 | — | — | — | — | 7 |
| Hepatitis c | D006526 | — | B19.2 | 7 | — | — | — | — | 7 |
| Therapeutic equivalency | D013810 | — | — | 7 | — | — | — | — | 7 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 5 | — | — | — | — | 5 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | 4 | 5 |
| Drug interactions | D004347 | — | — | 4 | — | — | — | 1 | 5 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | — | — | — | — | 4 |
| Dyslipidemias | D050171 | — | — | 4 | — | — | — | — | 4 |
Show 94 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 3 | 3 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Venous thrombosis | D020246 | — | I82.40 | — | — | — | — | 2 | 2 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | — | — | — | — | 1 | 1 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
Show 39 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Norgestrel |
| INN | norgestrel |
| 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 class | estrogens; progestins |
| Image (chem structure or protein) |  |
| 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-ID | 6533-00-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107797 |
| ChEBI ID | — |
| PubChem CID | 16051930 |
| DrugBank | DB00506 |
| UNII ID | 3J8Q1747Z2 (ChemIDplus, GSRS) |
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Estimated US medical usage
Norgestrel
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Ethinyl estradiol
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Norgestrel
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 1,280 documents
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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
Top Adverse Reactions
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123,657 adverse events reported
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