Entecavir
- Product NDC
- 68382-921
- 11-digit product format
- 683820921
- Labeler code
- 68382
- Product ID
- 68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- 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 |
|---|
| 68382-921-01 | Entecavir | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 68382-921-06 | Entecavir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 68382-921-16 | Entecavir | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
| 68382-921-30 | Entecavir | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 10 |
| 68382-921-77 | Entecavir | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-921 | ENTECAVIR TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 5 package rows | 20231011_b4fd0e22-ad23-4f51-9b98-95182f63c2eb.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 |
|---|
| 68382-921-01 | 68382092101 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-921-06 | 68382092106 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-921-16 | 68382092116 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-921-30 | 68382092130 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-921-77 | 68382092177 | 10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30) | 10 blister pack | 2017-08-10 | 0000-00-00 | No | No | Current |