Bicalutamide
- Product NDC
- 68382-224
- 11-digit product format
- 683820224
- Labeler code
- 68382
- Product ID
- 68382-224_e0e4d926-f498-4291-bfdb-37201e524374
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA079089
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-224-01 | 68382022401 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-224-01) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 68382-224-05 | 68382022405 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 68382-224-06 | 68382022406 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-224-06) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 68382-224-10 | 68382022410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-224-10) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 68382-224-77 | 68382022477 | 100 BLISTER PACK in 1 CARTON (68382-224-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-224-30) | 100 blister pack | 2009-07-06 | 0000-00-00 | No | No | Current |