entecavir

Generic: entecavir

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-216
Product ID 60687-216_1fbb7ecd-d5f8-a13d-e063-6294a90afc16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206217
Listing Expiration 2026-12-31
Marketing Start 2016-08-12

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 60687216
Hyphenated Format 60687-216

Supplemental Identifiers

RxCUI
485434
UNII
5968Y6H45M

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 ANDA206217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) / 1 TABLET in 1 BLISTER PACK (60687-216-95)
source: ndc

Packages (1)

60687-216-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) / 1 TABLET in 1 BLISTER PACK (60687-216-95)

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": "1fbb7ecd-d5f8-a13d-e063-6294a90afc16", "openfda": {"unii": ["5968Y6H45M"], "rxcui": ["485434"], "spl_set_id": ["a0d2e00d-21f0-4449-93b7-a19fa284d51d"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25)  / 1 TABLET in 1 BLISTER PACK (60687-216-95)", "package_ndc": "60687-216-25", "marketing_start_date": "20160812"}], "brand_name": "Entecavir", "product_id": "60687-216_1fbb7ecd-d5f8-a13d-e063-6294a90afc16", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "60687-216", "generic_name": "Entecavir", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entecavir", "active_ingredients": [{"name": "ENTECAVIR", "strength": ".5 mg/1"}], "application_number": "ANDA206217", "marketing_category": "ANDA", "marketing_start_date": "20160812", "listing_expiration_date": "20261231"}