bicalutamide
- Product NDC
- 82804-082
- 11-digit product format
- 828040082
- Labeler code
- 82804
- Product ID
- 82804-082_10e21544-f181-4cf8-9824-df0f49d19511
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA079110
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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 |
|---|
| 82804-082-90 | bicalutamide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-082 | BICALUTAMIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20240316_10e21544-f181-4cf8-9824-df0f49d19511.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-082-90 | 82804008290 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-082-90) | 2024-03-13 | No | No | Current |