Capecitabine
- Product NDC
- 0378-2512
- 11-digit product format
- 003782512
- Labeler code
- 0378
- Product ID
- 0378-2512_a38e2215-77d1-4671-8093-746efa1c5344
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090943
- Marketing category
- ANDA
- Marketing start
- 2014-08-08
- Marketing end
- 2023-06-30
- Substance
- CAPECITABINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-2512-78 | 00378251278 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-78) | 2014-08-08 | 0000-00-00 | No | No | Current |