abacavir sulfate

Generic: abacavir sulfate

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

Drug Facts

Product Profile

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

abacavir sulfate 300 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4105
Product ID 0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091294
Listing Expiration 2026-12-31
Marketing Start 2012-06-19

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 03784105
Hyphenated Format 0378-4105

Supplemental Identifiers

RxCUI
242679
UPC
0303784105917
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 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
  • 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0378-4105-91 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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": "3ae56d4c-73b4-497f-bc93-554a247f2359", "openfda": {"upc": ["0303784105917"], "unii": ["J220T4J9Q2"], "rxcui": ["242679"], "spl_set_id": ["5676d391-f9a4-44be-9604-954b3d8d0e2b"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "0378-4105-91", "marketing_start_date": "20120619"}], "brand_name": "Abacavir Sulfate", "product_id": "0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359", "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": "0378-4105", "generic_name": "abacavir sulfate", "labeler_name": "Mylan Pharmaceuticals 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": "20120619", "listing_expiration_date": "20261231"}