abacavir

Generic: abacavir

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

Drug Facts

Product Profile

Brand Name abacavir
Generic Name abacavir
Labeler cipla usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abacavir sulfate 300 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-514
Product ID 69097-514_cf84089d-b713-40b8-a815-b66f4119982e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078119
Listing Expiration 2026-12-31
Marketing Start 2017-11-21

Pharmacologic Class

Classes
human immunodeficiency 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 69097514
Hyphenated Format 69097-514

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 ANDA078119 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)
source: ndc

Packages (1)

69097-514-03 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)

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": "cf84089d-b713-40b8-a815-b66f4119982e", "openfda": {"unii": ["J220T4J9Q2"], "rxcui": ["242679"], "spl_set_id": ["0d791375-e311-41f9-87b8-940657e6318c"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)", "package_ndc": "69097-514-03", "marketing_start_date": "20171121"}], "brand_name": "Abacavir", "product_id": "69097-514_cf84089d-b713-40b8-a815-b66f4119982e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "69097-514", "generic_name": "Abacavir", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA078119", "marketing_category": "ANDA", "marketing_start_date": "20171121", "listing_expiration_date": "20261231"}