Entecavir
- Product NDC
- 65162-449
- 11-digit product format
- 651620449
- Labeler code
- 65162
- Product ID
- 65162-449_c0f7f2de-7a13-4703-9569-262ea1f20cff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA206652
- Marketing category
- ANDA
- Marketing start
- 2014-11-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Entecavir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTECAVIR | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5968Y6H45M |
| Rxcui | 485436, 485434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-449-03 | Entecavir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-449 | ENTECAVIR TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 19 | Current NDC, Legacy NDC, 1 package rows | 20241027_007a6ad8-4d23-4543-ae48-c651cac7dd7b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-449-03 | 65162044903 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-449-03) | 2014-11-28 | 0000-00-00 | No | No | Current |