Entecavir
- Product NDC
- 16729-389
- 11-digit product format
- 167290389
- Labeler code
- 16729
- Product ID
- 16729-389_bae56d70-2cec-84eb-e053-2995a90a0ccd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA205824
- Marketing category
- ANDA
- Marketing start
- 2017-08-25
- Marketing end
- 0000-00-00
- Substance
- ENTECAVIR
- Active strength
- 1 mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 16729-389-10 | 16729038910 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-389-10) | 2017-08-25 | 0000-00-00 | No | No | Current |