Entecavir
- Product NDC
- 60687-216
- 11-digit product format
- 606870216
- Labeler code
- 60687
- Product ID
- 60687-216_1fbb7ecd-d5f8-a13d-e063-6294a90afc16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA206217
- Marketing category
- ANDA
- Marketing start
- 2016-08-12
- Substance
- ENTECAVIR
- Active strength
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5968Y6H45M |
| Rxcui | 485434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-216-25 | Entecavir | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | | 8 |
| 60687-216-95 | Entecavir | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-216 | ENTECAVIR TABLET [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240816_a0d2e00d-21f0-4449-93b7-a19fa284d51d.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 |
|---|
| 60687-216-25 | 60687021625 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) / 1 TABLET in 1 BLISTER PACK (60687-216-95) | 30 blister pack | 2016-08-12 | 0000-00-00 | No | No | Current |
| 60687-216-95 | 60687021695 | 1 in 1 BLISTER PACK | | | | | | Historical |