ENTECAVIR
- Product NDC
- 43547-437
- 11-digit product format
- 435470437
- Labeler code
- 43547
- Product ID
- 43547-437_a5a51ce6-2c18-40de-b266-c3891132bbd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTECAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA208782
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- Substance
- ENTECAVIR ANHYDROUS
- 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 ANHYDROUS | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NNU2O4609D |
| Rxcui | 485434, 485436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-437-03 | ENTECAVIR | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 43547-437-09 | ENTECAVIR | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
| 43547-437-50 | ENTECAVIR | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-437 | ENTECAVIR TABLET, FILM COATED [SOLCO HEALTHCARE LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240801_bb1bb6dc-0120-46e2-ad1e-d9afc221fa16.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 |
|---|
| 43547-437-03 | 43547043703 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03) | 2018-04-01 | 0000-00-00 | No | No | Current |
| 43547-437-09 | 43547043709 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09) | 2018-04-01 | 0000-00-00 | No | No | Current |
| 43547-437-15 | 43547043715 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-15) | 2018-04-01 | 0000-00-00 | No | No | Current |
| 43547-437-50 | 43547043750 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50) | 2018-04-01 | 0000-00-00 | No | No | Current |