entecavir

Generic: entecavir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entecavir
Generic Name entecavir
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entecavir .5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-841
Product ID 65862-841_81e4395b-8a3e-466e-b039-0a804f171b43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206217
Listing Expiration 2026-12-31
Marketing Start 2015-08-26

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 65862841
Hyphenated Format 65862-841

Supplemental Identifiers

RxCUI
485434 485436
UPC
0365862841308
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 ANDA206217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-841-30) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65862-841-90) / 90 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65862-841-99) / 1000 TABLET in 1 BOTTLE
source: ndc

Packages (3)

65862-841-30 1 BOTTLE in 1 CARTON (65862-841-30) / 30 TABLET in 1 BOTTLE 65862-841-90 1 BOTTLE in 1 CARTON (65862-841-90) / 90 TABLET in 1 BOTTLE 65862-841-99 1 BOTTLE in 1 CARTON (65862-841-99) / 1000 TABLET in 1 BOTTLE

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": "81e4395b-8a3e-466e-b039-0a804f171b43", "openfda": {"upc": ["0365862841308"], "unii": ["5968Y6H45M"], "rxcui": ["485434", "485436"], "spl_set_id": ["def332bf-2906-4a6c-b85d-dfb56bb94312"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-841-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "65862-841-30", "marketing_start_date": "20150826"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-841-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "65862-841-90", "marketing_start_date": "20150826"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-841-99)  / 1000 TABLET in 1 BOTTLE", "package_ndc": "65862-841-99", "marketing_start_date": "20150826"}], "brand_name": "Entecavir", "product_id": "65862-841_81e4395b-8a3e-466e-b039-0a804f171b43", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-841", "generic_name": "Entecavir", "labeler_name": "Aurobindo Pharma Limited", "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": "20150826", "listing_expiration_date": "20261231"}