abacavir

Generic: abacavir

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abacavir
Generic Name abacavir
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

abacavir sulfate 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1602
Product ID 67046-1602_48c0d443-a111-0039-e063-6394a90a9076
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091560
Listing Expiration 2027-12-31
Marketing Start 2021-04-01

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 670461602
Hyphenated Format 67046-1602

Supplemental Identifiers

RxCUI
242679
UNII
J220T4J9Q2

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 ANDA091560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1602-3)
source: ndc

Packages (1)

67046-1602-3 30 TABLET in 1 BLISTER PACK (67046-1602-3)

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": "48c0d443-a111-0039-e063-6394a90a9076", "openfda": {"unii": ["J220T4J9Q2"], "rxcui": ["242679"], "spl_set_id": ["42ca758a-1694-c614-e063-6294a90a8c7e"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1602-3)", "package_ndc": "67046-1602-3", "marketing_start_date": "20210401"}], "brand_name": "Abacavir", "product_id": "67046-1602_48c0d443-a111-0039-e063-6394a90a9076", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 1A1 Inhibitors [MoA]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "67046-1602", "generic_name": "Abacavir", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA091560", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20271231"}