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NDC 68382-0920-01 Entecavir 0.5 mg/1 Details
Entecavir 0.5 mg/1
Entecavir is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. 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: 68382-0920-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Entecavir
Product Information
| NDC | 68382-0920 |
|---|---|
| Product ID | 68382-920_b9646f09-8d5b-4271-b2b1-b1d66a91ed73 |
| Associated GPIs | 12352030000320 |
| GCN Sequence Number | 058934 |
| GCN Sequence Number Description | entecavir TABLET 0.5 MG ORAL |
| HIC3 | W5F |
| HIC3 Description | HEPATITIS B TREATMENT AGENTS |
| GCN | 24466 |
| HICL Sequence Number | 032832 |
| HICL Sequence Number Description | ENTECAVIR |
| Brand/Generic | Generic |
| Proprietary Name | Entecavir |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Entecavir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ENTECAVIR |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| 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 | ANDA |
| Application Number | ANDA206745 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0920-01 (68382092001)
| NDC Package Code | 68382-920-01 |
|---|---|
| Billing NDC | 68382092001 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (68382-920-01) |
| Marketing Start Date | 2017-08-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |