BARACLUDE
- Product NDC
- 0003-1614
- 11-digit product format
- 000031614
- Labeler code
- 0003
- Product ID
- 0003-1614_275a2584-65d6-40f8-8aac-49eb54479f6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- entecavir
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA021798
- Marketing category
- NDA
- Marketing start
- 2005-03-29
- Substance
- ENTECAVIR
- Active strength
- .05 mg/mL
- 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
- BARACLUDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTECAVIR | .05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5968Y6H45M |
| Rxcui | 485434, 485436, 485536, 578457, 578459, 607579 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-1614-12 | BARACLUDE | 1 in 1 CARTON | SOLUTION | 1 | | 42 |
| 0003-1614-12 | BARACLUDE | 210 mL in 1 BOTTLE | SOLUTION | 210 | | 42 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| entecavir | ACTIVE INGREDIENT | 5968Y6H45M | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| entecavir anhydrous | ACTIVE MOIETY | NNU2O4609D | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| maltitol | INACTIVE INGREDIENT | D65DG142WK | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-1614 | BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 41 | Current NDC, Legacy NDC, 2 package rows | 20240510_046e61c9-9298-4b2e-b76e-b26b81fecd20.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 |
|---|
| 0003-1614-12 | 00003161412 | 1 BOTTLE in 1 CARTON (0003-1614-12) / 210 mL in 1 BOTTLE | 1 bottle | 2005-03-29 | 0000-00-00 | No | No | Current |