entecavir

Generic: entecavir

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entecavir 1 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-921
Product ID 68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206745
Listing Expiration 2026-12-31
Marketing Start 2017-08-10

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 68382921
Hyphenated Format 68382-921

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 ANDA206745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)
  • 10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)
source: ndc

Packages (4)

68382-921-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01) 68382-921-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06) 68382-921-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16) 68382-921-77 10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)

Ingredients (1)

entecavir (1 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": "b9646f09-8d5b-4271-b2b1-b1d66a91ed73", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["b4fd0e22-ad23-4f51-9b98-95182f63c2eb"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)", "package_ndc": "68382-921-01", "marketing_start_date": "20170810"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)", "package_ndc": "68382-921-06", "marketing_start_date": "20170810"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)", "package_ndc": "68382-921-16", "marketing_start_date": "20170810"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-921-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)", "package_ndc": "68382-921-77", "marketing_start_date": "20170810"}], "brand_name": "Entecavir", "product_id": "68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73", "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": "68382-921", "generic_name": "Entecavir", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": "1 mg/1"}], "application_number": "ANDA206745", "marketing_category": "ANDA", "marketing_start_date": "20170810", "listing_expiration_date": "20261231"}