bicalutamide
- Product NDC
- 67253-191
- 11-digit product format
- 672530191
- Labeler code
- 67253
- Product ID
- 67253-191_0353c7a7-53e1-4628-8585-049afbc48c1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dava Pharmaceuticals, Inc.
- Application
- ANDA077973
- Marketing category
- ANDA
- Marketing start
- 2009-07-06
- Marketing end
- 0000-00-00
- Substance
- BICALUTAMIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| bicalutamide | ACTIVE INGREDIENT | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| bicalutamide | ACTIVE MOIETY | A0Z3NAU9DP | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67253-191 | BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] | 1 | Legacy NDC | 20090814_59df7b06-81d0-423c-9e80-9014d424b64c.zip |