Entecavir
- Product NDC
- 31722-833
- 11-digit product format
- 317220833
- Labeler code
- 31722
- Product ID
- 31722-833_2b442999-71b5-88f6-e063-6394a90a9d6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entecavir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA205740
- Marketing category
- ANDA
- Marketing start
- 2015-08-21
- Substance
- ENTECAVIR ANHYDROUS
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTECAVIR ANHYDROUS | .5 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 |
|---|
| 31722-833-30 | Entecavir | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 31722-833-31 | Entecavir | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 31722-833-32 | Entecavir | 100 in 1 CARTON | TABLET | 100 | | 4 |
| 31722-833-90 | Entecavir | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ENTECAVIR ANHYDROUS | ACTIVE INGREDIENT | NNU2O4609D | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| ENTECAVIR ANHYDROUS | ACTIVE MOIETY | NNU2O4609D | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| THIAMINE MONONITRATE | INACTIVE INGREDIENT | 8K0I04919X | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-833 | ENTECAVIR (ENTECAVIR) TABLET ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250112_01ec50a1-6c6c-46f0-8c74-73542b0a59c3.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 |
|---|
| 31722-833-30 | 31722083330 | 30 TABLET in 1 BOTTLE (31722-833-30) | 30 tablet | 2015-08-21 | 0000-00-00 | No | No | Current |
| 31722-833-31 | 31722083331 | 10 TABLET in 1 BLISTER PACK (31722-833-31) | 10 tablet | 2015-08-21 | 0000-00-00 | No | No | Current |
| 31722-833-32 | 31722083332 | 100 TABLET in 1 CARTON (31722-833-32) | 100 tablet | 2015-08-21 | 0000-00-00 | No | No | Current |
| 31722-833-90 | 31722083390 | 90 TABLET in 1 BOTTLE (31722-833-90) | 90 tablet | 2015-08-21 | 0000-00-00 | No | No | Current |