entecavir

Generic: entecavir

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-446
Product ID 65162-446_c0f7f2de-7a13-4703-9569-262ea1f20cff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206652
Listing Expiration 2026-12-31
Marketing Start 2014-11-28

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 65162446
Hyphenated Format 65162-446

Supplemental Identifiers

RxCUI
485434 485436
UPC
0365162446036 0365162449037
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 (65162-446-03)
source: ndc

Packages (1)

65162-446-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-446-03)

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": "c0f7f2de-7a13-4703-9569-262ea1f20cff", "openfda": {"upc": ["0365162446036", "0365162449037"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["007a6ad8-4d23-4543-ae48-c651cac7dd7b"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-446-03)", "package_ndc": "65162-446-03", "marketing_start_date": "20141128"}], "brand_name": "Entecavir", "product_id": "65162-446_c0f7f2de-7a13-4703-9569-262ea1f20cff", "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": "65162-446", "generic_name": "Entecavir", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "20141128", "listing_expiration_date": "20261231"}