abacavir sulfate

Generic: abacavir sulfate

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abacavir sulfate
Generic Name abacavir sulfate
Labeler mylan institutional inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abacavir sulfate 300 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-204
Product ID 51079-204_3a22f5ef-d757-6414-e063-6294a90af7de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091294
Listing Expiration 2026-12-31
Marketing Start 2012-08-01

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 51079204
Hyphenated Format 51079-204

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 sulfate (source: ndc)
Generic Name abacavir sulfate (source: ndc)
Application Number ANDA091294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)
source: ndc

Packages (1)

51079-204-06 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)

Ingredients (1)

abacavir sulfate (300 mg/1)

Linked Drug Pages (1)

Abacavir Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a22f5ef-d757-6414-e063-6294a90af7de", "openfda": {"unii": ["J220T4J9Q2"], "rxcui": ["242679"], "spl_set_id": ["80c1702a-973c-436a-90f8-69b29674dca0"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (51079-204-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)", "package_ndc": "51079-204-06", "marketing_start_date": "20120801"}], "brand_name": "Abacavir Sulfate", "product_id": "51079-204_3a22f5ef-d757-6414-e063-6294a90af7de", "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": "51079-204", "generic_name": "abacavir sulfate", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir Sulfate", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA091294", "marketing_category": "ANDA", "marketing_start_date": "20120801", "listing_expiration_date": "20261231"}