Entecavir
- Product NDC
- 42806-668
- 11-digit product format
- 428060668
- Labeler code
- 42806
- Product ID
- 42806-668_d69451df-e204-4a5c-a2bb-9e6d4d519302
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- entecavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA216857
- Marketing category
- ANDA
- Marketing start
- 2022-10-31
- Substance
- ENTECAVIR ANHYDROUS
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Entecavir
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTECAVIR ANHYDROUS | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NNU2O4609D |
| Rxcui | 485434, 485436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-668-30 | Entecavir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 42806-668-30 | Entecavir | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-668-30 | 42806066830 | 1 BOTTLE in 1 CARTON (42806-668-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-11-01 | No | No | Historical |