ENTECAVIR
- Product NDC
- 42494-458
- 11-digit product format
- 424940458
- Labeler code
- 42494
- Product ID
- 42494-458_3ada45bd-97aa-4713-ad29-6e462668c108
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTECAVIR ANHYDROUS
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cameron Pharmaceuticals
- Application
- ANDA216857
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- 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
- 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 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 |
|---|
| 42494-458-30 | ENTECAVIR | 30 in 1 BOTTLE | TABLET | 30 | | 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 |
|---|
| 42494-458-30 | 42494045830 | 30 TABLET in 1 BOTTLE (42494-458-30) | 30 tablet | 2025-05-15 | No | No | Current |