bicalutamide
- Product NDC
- 47335-485
- 11-digit product format
- 473350485
- Labeler code
- 47335
- Product ID
- 47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- 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 |
|---|
| 47335-485-08 | bicalutamide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 47335-485-18 | bicalutamide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 47335-485-83 | bicalutamide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 47335-485-88 | bicalutamide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BICALUTAMIDE | ACTIVE INGREDIENT | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| BICALUTAMIDE | ACTIVE MOIETY | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-485 | BICALUTAMIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250130_8b533fe4-287f-482c-b530-d9a5bf2ce40c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-485-08 | 47335048508 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-485-18 | 47335048518 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-485-83 | 47335048583 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-485-88 | 47335048588 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88) | 2014-12-15 | 0000-00-00 | No | No | Current |