Active ingredient
Clomiphene
11 finished FDA listings contain Clomiphene as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLOMIPHENE CITRATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 50 mg/1
- Brand names in FDA listings
- Clomid, Clomiphene Citrate, Milophene
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2596
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 072196 | GRANATA BIO CORP | 1988-12-20 | 1 |
| ANDA 075528 | COSETTE | 1999-08-30 | 3 |
| ANDA 216739 | APPCO | 2024-11-08 | 3 |
| ANDA 216545 | RUBICON RESEARCH | 2024-11-12 | 1 |
| ANDA 219406 | ACCORD HLTHCARE | 2025-10-03 | 1 |
| ANDA 219781 | NOVITIUM PHARMA | 2025-10-17 | 1 |
| ANDA 220673 | ASCENT PHARMS INC | 2026-05-15 | 1 |
Official labeling on DailyMed
- CLOMIPHENE CITRATE TABLET [CAMBER PHARMACEUTICALS INC] · version 1 · 2026-09-02
- CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [ACETRIS PHARMA HOLDINGS, LLC] · version 1 · 2026-06-30
- CLOMIPHENE CITRATE TABLET [ANI PHARMACEUTICALS, INC.] · version 2 · 2026-06-15
- CLOMIPHENE CITRATE TABLET [ACCORD HEALTHCARE INC.] · version 3 · 2025-12-02
- CLOMIPHENE CITRATE TABLET [ADVAGEN PHARMA LTD] · version 3 · 2025-11-17
- MILOPHENE (CLOMIPHENE CITRATE) TABLET [BUREL PHARMACEUTICALS, LLC] · version 2 · 2025-11-17
- CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [RISING PHARMA HOLDINGS, INC.] · version 2 · 2025-09-25
- CLOMIPHENE CITRATE TABLET [COSETTE PHARMACEUTICALS NC LABORATORIES, LLC] · version 4 · 2025-08-25
- CLOMID (CLOMIPHENE CITRATE) TABLET [COSETTE PHARMACEUTICALS, INC.] · version 3 · 2025-02-03
- CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [APPCO PHARMA LLC] · version 4 · 2024-12-02
- CLOMID (CLOMIPHENE CITRATE) TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2023-06-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.