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NDC 00003-1612-12 BARACLUDE 1 mg/1 Details
BARACLUDE 1 mg/1
BARACLUDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E.R. Squibb & Sons, L.L.C.. The primary component is ENTECAVIR.
MedlinePlus Drug Summary
Entecavir is used to treat chronic (long-term) hepatitis B infection (swelling of the liver caused by a virus) in adults and children 2 years of age and older who have liver damage. Entecavir is in a class of medications called nucleoside analogs. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Entecavir does not cure HBV and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Entecavir does not prevent the spread of HBV to other people.
Related Packages: 00003-1612-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Entecavir
Product Information
| NDC | 00003-1612 |
|---|---|
| Product ID | 0003-1612_5ea9d52c-ff85-43a8-a663-73e4f77a43d1 |
| Associated GPIs | 12352030000330 |
| GCN Sequence Number | 058935 |
| GCN Sequence Number Description | entecavir TABLET 1 MG ORAL |
| HIC3 | W5F |
| HIC3 Description | HEPATITIS B TREATMENT AGENTS |
| GCN | 24467 |
| HICL Sequence Number | 032832 |
| HICL Sequence Number Description | ENTECAVIR |
| Brand/Generic | Brand |
| Proprietary Name | BARACLUDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | entecavir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | ENTECAVIR |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Pharmaceutical Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021797 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00003-1612-12 (00003161212)
| NDC Package Code | 0003-1612-12 |
|---|---|
| Billing NDC | 00003161212 |
| Package | 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2005-03-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |