ENTECAVIR
- Product NDC
- 16714-717
- 11-digit product format
- 167140717
- Labeler code
- 16714
- Product ID
- 16714-717_3e6a4c6c-0a9e-4ffd-b8e0-853bbfa961a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTECAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA206872
- Marketing category
- ANDA
- Marketing start
- 2017-06-15
- 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
- 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 | .5 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 |
|---|
| 16714-717-01 | ENTECAVIR | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-717 | ENTECAVIR TABLET, FILM COATED [NORTHSTAR RXLLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20221125_da705339-c349-444f-a058-4f0cef2864bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-717-01 | 16714071701 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01) | 2017-06-15 | 0000-00-00 | No | No | Current |