Entecavir
- Product NDC
- 42806-659
- 11-digit product format
- 428060659
- Labeler code
- 42806
- Product ID
- 42806-659_db290579-c9e1-44be-b03c-ad8a7efe5ce1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA212126
- Marketing category
- ANDA
- Marketing start
- 2020-06-02
- 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
- 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 | 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 |
|---|
| 42806-659-30 | Entecavir | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-659 | ENTECAVIR TABLET [EPIC PHARMA, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241211_af4f47e2-f556-40f2-a0fd-ff81e9f27429.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 |
|---|
| 42806-659-30 | 42806065930 | 30 TABLET in 1 BOTTLE, PLASTIC (42806-659-30) | 30 tablet | 2020-06-02 | 0000-00-00 | No | No | Current |