Entecavir
- Product NDC
- 70771-1020
- 11-digit product format
- 707711020
- Labeler code
- 70771
- Product ID
- 70771-1020_eb274d01-4108-4d2e-8e2b-8656b90684c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA206745
- Marketing category
- ANDA
- Marketing start
- 2017-08-10
- 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 | 485434, 485436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1020-1 | Entecavir | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 70771-1020-2 | Entecavir | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 70771-1020-3 | Entecavir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 70771-1020-4 | Entecavir | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 70771-1020-9 | Entecavir | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1020 | ENTECAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 6 | Current NDC, Legacy NDC, 5 package rows | 20241201_0e3b2a0a-9076-4907-bbaf-eb6a65bb9481.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1020-1 | 70771102001 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1020-1) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 70771-1020-2 | 70771102002 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1020-3 | 70771102003 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1020-3) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 70771-1020-4 | 70771102004 | 10 BLISTER PACK in 1 CARTON (70771-1020-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1020-2) | 10 blister pack | 2017-08-10 | 0000-00-00 | No | No | Current |
| 70771-1020-9 | 70771102009 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1020-9) | | 2017-08-10 | 0000-00-00 | No | No | Current |