Entecavir
- Product NDC
- 61442-311
- 11-digit product format
- 614420311
- Labeler code
- 61442
- Product ID
- 61442-311_48618328-e6d6-2aa2-e063-6294a90a1d00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carlsbad Technology, Inc.
- Application
- ANDA208195
- Marketing category
- ANDA
- Marketing start
- 2021-11-10
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61442-311-30 | Entecavir | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61442-311 | ENTECAVIR TABLET [CARLSBAD TECHNOLOGY, INC.] | 1 | Current NDC, 1 package rows | 20240709_1a905283-0057-a7dd-e063-6394a90a1909.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61442-311-30 | 61442031130 | 30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30) | 30 tablet | 2021-11-10 | No | No | Current |