Bicalutamide
- Product NDC
- 72578-215
- 11-digit product format
- 725780215
- Labeler code
- 72578
- Product ID
- 72578-215_7f9961d0-109d-4640-bedc-319663483652
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc.
- Application
- ANDA079089
- Marketing category
- ANDA
- Marketing start
- 2009-06-07
- Substance
- BICALUTAMIDE
- Active strength
- 50 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
- Bicalutamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BICALUTAMIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A0Z3NAU9DP |
| Rxcui | 199123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72578-215-01 | Bicalutamide | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 72578-215-06 | Bicalutamide | 30 in 1 BOTTLE | 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 |
|---|
| 72578-215-01 | 72578021501 | 100 TABLET in 1 BOTTLE (72578-215-01) | 100 tablet | 2009-06-07 | No | No | Historical |
| 72578-215-06 | 72578021506 | 30 TABLET in 1 BOTTLE (72578-215-06) | 30 tablet | 2009-06-07 | No | No | Historical |