ENTECAVIR
- Product NDC
- 69097-426
- 11-digit product format
- 690970426
- Labeler code
- 69097
- Product ID
- 69097-426_f11e1153-612f-4924-86b1-6739d755e3c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTECAVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA206872
- Marketing category
- ANDA
- Marketing start
- 2016-12-06
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTECAVIR | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5968Y6H45M |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-426-02 | ENTECAVIR | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 16 |
| 69097-426-05 | ENTECAVIR | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-426 | ENTECAVIR TABLET, FILM COATED [CIPLA USA INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20221227_d59e9ea4-09ea-47bd-af2f-39f7a2e2aceb.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 |
|---|
| 69097-426-02 | 69097042602 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-02) | 2016-12-06 | 0000-00-00 | No | No | Current |
| 69097-426-05 | 69097042605 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-05) | 2016-12-06 | 0000-00-00 | No | No | Current |