Entecavir
- Product NDC
- 51991-895
- 11-digit product format
- 519910895
- Labeler code
- 51991
- Product ID
- 51991-895_b91cc0f3-f252-48f8-8623-41ad9ee59af4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA208721
- Marketing category
- ANDA
- Marketing start
- 2018-03-16
- Marketing end
- 2025-01-31
- 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
- 0000-00-00
- 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 |
|---|
| 51991-895-33 | 51991089533 | 30 TABLET in 1 BOTTLE, PLASTIC (51991-895-33) | 30 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |
| 51991-895-90 | 51991089590 | 90 TABLET in 1 BOTTLE, PLASTIC (51991-895-90) | 90 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |