abacavir

Generic: abacavir

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

Drug Facts

Product Profile

Brand Name abacavir
Generic Name abacavir
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abacavir sulfate 300 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-073
Product ID 65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077844
Listing Expiration 2026-12-31
Marketing Start 2012-12-17

Pharmacologic Class

Classes
cytochrome p450 1a1 inhibitors [moa] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862073
Hyphenated Format 65862-073

Supplemental Identifiers

RxCUI
242679
UNII
J220T4J9Q2

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 abacavir (source: ndc)
Generic Name abacavir (source: ndc)
Application Number ANDA077844 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)
source: ndc

Packages (1)

65862-073-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)

Ingredients (1)

abacavir sulfate (300 mg/1)

Linked Drug Pages (1)

Abacavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4", "openfda": {"unii": ["J220T4J9Q2"], "rxcui": ["242679"], "spl_set_id": ["5409c8ed-17c3-454f-bb88-d597ba8f84ec"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)", "package_ndc": "65862-073-60", "marketing_start_date": "20121217"}], "brand_name": "Abacavir", "product_id": "65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A1 Inhibitors [MoA]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-073", "generic_name": "Abacavir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA077844", "marketing_category": "ANDA", "marketing_start_date": "20121217", "listing_expiration_date": "20261231"}