Clomiphene citrate
- Product NDC
- 70954-825
- 11-digit product format
- 709540825
- Labeler code
- 70954
- Product ID
- 70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clomiphene citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219781
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOMIPHENE CITRATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1B8447E7YI |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-825-10 | Clomiphene citrate | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 70954-825-20 | Clomiphene citrate | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 70954-825-30 | Clomiphene citrate | 30 in 1 CARTON | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-825-10 | 70954082510 | 1 in 1 BLISTER PACK | | | | | Historical |
| 70954-825-20 | 70954082520 | 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10) | 10 blister pack | 2025-10-17 | No | No | Current |
| 70954-825-30 | 70954082530 | 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10) | 30 blister pack | 2025-10-17 | No | No | Current |