MiloPhene
- Product NDC
- 35573-470
- 11-digit product format
- 355730470
- Labeler code
- 35573
- Product ID
- 35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clomiphene Citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA072196
- Marketing category
- ANDA
- Marketing start
- 2025-08-15
- 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
- MiloPhene
- 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, 2723329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-470-30 | MiloPhene | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 35573-470-75 | MiloPhene | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 35573-470-30 | 35573047030 | 30 TABLET in 1 BOTTLE (35573-470-30) | 30 tablet | 2025-08-15 | No | No | Current |
| 35573-470-75 | 35573047075 | 10 TABLET in 1 BOTTLE (35573-470-75) | 10 tablet | 2025-12-01 | No | No | Current |