Nilutamide
- Product NDC
- 62559-173
- 11-digit product format
- 625590173
- Labeler code
- 62559
- Product ID
- 62559-173_441002fd-1e82-482c-acab-560838b7118f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nilutamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA207631
- Marketing category
- ANDA
- Marketing start
- 2016-07-18
- Substance
- NILUTAMIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nilutamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NILUTAMIDE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 51G6I8B902 |
| Rxcui | 311982 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-173-31 | Nilutamide | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 62559-173-31 | Nilutamide | 3 in 1 CARTON | TABLET | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-173 | NILUTAMIDE TABLET [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200916_d5740b8f-fbb3-4023-9133-9e359a9ab980.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62559-173-31 | 62559017331 | 3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2016-07-18 | 0000-00-00 | No | No | Current |