entecavir

Generic: entecavir

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-261
Product ID 42291-261_485b9c2c-4461-5cf2-e063-6394a90a625c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206652
Listing Expiration 2027-12-31
Marketing Start 2020-11-02

Pharmacologic Class

Classes
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside analog [ext] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291261
Hyphenated Format 42291-261

Supplemental Identifiers

RxCUI
485434 485436
UNII
5968Y6H45M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name entecavir (source: ndc)
Generic Name entecavir (source: ndc)
Application Number ANDA206652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-261-30)
source: ndc

Packages (1)

42291-261-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-261-30)

Ingredients (1)

entecavir (.5 mg/1)

Linked Drug Pages (1)

Entecavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "485b9c2c-4461-5cf2-e063-6394a90a625c", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["5a1cbf7e-0352-aa3b-080c-222a6423ecd8"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-261-30)", "package_ndc": "42291-261-30", "marketing_start_date": "20201102"}], "brand_name": "Entecavir", "product_id": "42291-261_485b9c2c-4461-5cf2-e063-6394a90a625c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "42291-261", "generic_name": "Entecavir", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": ".5 mg/1"}], "application_number": "ANDA206652", "marketing_category": "ANDA", "marketing_start_date": "20201102", "listing_expiration_date": "20271231"}