Bicalutamide
- Product NDC
- 65841-613
- 11-digit product format
- 658410613
- Labeler code
- 65841
- Product ID
- 65841-613_03a74f00-132e-4a48-ba2e-4adf7c3f3170
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 65841-613-01 | 65841061301 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-613-01) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 65841-613-05 | 65841061305 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-613-05) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 65841-613-06 | 65841061306 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-613-06) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 65841-613-10 | 65841061310 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-613-10) | | 2009-07-06 | 0000-00-00 | No | No | Current |
| 65841-613-30 | 65841061330 | 10 BLISTER PACK in 1 CARTON (65841-613-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2009-07-06 | 0000-00-00 | No | No | Current |