Entecavir
- Product NDC
- 60050-057
- 11-digit product format
- 600500057
- Labeler code
- 60050
- Product ID
- 60050-057_ad4c17ed-625a-de38-e053-2995a90a16c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Pharmadax Inc.
- Application
- ANDA212106
- Marketing category
- ANDA
- Marketing start
- 2020-12-01
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60050-057-10 | 60050005710 | 1000 TABLET in 1 BOTTLE (60050-057-10) | 1000 tablet | 2020-12-01 | 0000-00-00 | No | No | Current |
| 60050-057-23 | 60050005723 | 30 TABLET in 1 BOTTLE (60050-057-23) | 30 tablet | 2020-12-01 | 0000-00-00 | No | No | Current |