Baclofen

Generic: Baclofen

Labeler: Mckesson Corporation DBA SKY Packaginng
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Baclofen
Generic Name Baclofen
Labeler Mckesson Corporation DBA SKY Packaginng
Dosage Form TABLET
Routes
ORAL
Active Ingredients

BACLOFEN 10 mg/1

Identifiers & Regulatory

Product NDC 63739-479
Product ID 63739-479_32721b87-aef0-d759-e063-6394a90a40d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078401
Marketing Start 2011-01-01
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63739479
Hyphenated Format 63739-479

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 Baclofen (source: ndc)
Generic Name Baclofen (source: ndc)
Application Number ANDA078401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-479-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

63739-479-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-479-10) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

BACLOFEN (10 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32721b87-aef0-d759-e063-6394a90a40d3", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392"], "spl_set_id": ["d0644a68-d1bf-4fe0-92e6-b79037cf4d12"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Mckesson Corporation DBA SKY Packaginng"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-479-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "63739-479-10", "marketing_end_date": "20260228", "marketing_start_date": "20160504"}], "brand_name": "Baclofen", "product_id": "63739-479_32721b87-aef0-d759-e063-6394a90a40d3", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "63739-479", "generic_name": "Baclofen", "labeler_name": "Mckesson Corporation DBA SKY Packaginng", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA078401", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20110101"}