Clomiphene Citrate
- Product NDC
- 83390-107
- 11-digit product format
- 833900107
- Labeler code
- 83390
- Product ID
- 83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clomiphene Citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals NC Laboratories, LLC
- Application
- ANDA075528
- Marketing category
- ANDA
- Marketing start
- 2025-08-21
- Substance
- CLOMIPHENE CITRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clomiphene Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOMIPHENE CITRATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1B8447E7YI |
| Rxcui | 1093060 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83390-107-09 | Clomiphene Citrate | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 83390-107-09 | Clomiphene Citrate | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 83390-107-30 | Clomiphene Citrate | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 83390-107-30 | Clomiphene Citrate | 3 in 1 CARTON | TABLET | 3 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83390-107-09 | 83390010709 | 1 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2025-08-21 | No | No | Current |
| 83390-107-30 | 83390010730 | 3 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-08-21 | No | No | Current |