Bicalutamide
- Product NDC
- 16729-023
- 11-digit product format
- 167290023
- Labeler code
- 16729
- Product ID
- 16729-023_0f1d66dd-3a8d-73a9-e063-6394a90ab5e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA078917
- Marketing category
- ANDA
- Marketing start
- 2009-07-06
- 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 |
|---|
| 16729-023-01 | Bicalutamide | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 16729-023-10 | Bicalutamide | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BICALUTAMIDE | ACTIVE INGREDIENT | A0Z3NAU9DP | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| BICALUTAMIDE | ACTIVE MOIETY | A0Z3NAU9DP | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| BICALUTAMIDE | ACTIVE INGREDIENT | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| BICALUTAMIDE | ACTIVE MOIETY | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-023 | BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240117_7c295b64-ec39-42ec-9f02-da5b42e775e1.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 |
|---|
| 16729-023-01 | 16729002301 | 100 TABLET in 1 BOTTLE (16729-023-01) | 100 tablet | 2009-07-06 | 0000-00-00 | No | No | Current |
| 16729-023-10 | 16729002310 | 30 TABLET in 1 BOTTLE (16729-023-10) | 30 tablet | 2009-07-06 | 0000-00-00 | No | No | Current |