baclofen

Generic: baclofen

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0478
Product ID 80425-0478_2cf6fc95-e6ff-0af3-e063-6294a90ac508
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214374
Listing Expiration 2026-12-31
Marketing Start 2025-01-30

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250478
Hyphenated Format 80425-0478

Supplemental Identifiers

RxCUI
197392
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 ANDA214374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0478-1)
  • 60 TABLET in 1 BOTTLE (80425-0478-2)
  • 90 TABLET in 1 BOTTLE (80425-0478-3)
  • 120 TABLET in 1 BOTTLE (80425-0478-4)
source: ndc

Packages (4)

80425-0478-1 30 TABLET in 1 BOTTLE (80425-0478-1) 80425-0478-2 60 TABLET in 1 BOTTLE (80425-0478-2) 80425-0478-3 90 TABLET in 1 BOTTLE (80425-0478-3) 80425-0478-4 120 TABLET in 1 BOTTLE (80425-0478-4)

Ingredients (1)

baclofen (20 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": "2cf6fc95-e6ff-0af3-e063-6294a90ac508", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["2cf71f5f-6d46-7506-e063-6294a90a186f"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0478-1)", "package_ndc": "80425-0478-1", "marketing_start_date": "20250130"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0478-2)", "package_ndc": "80425-0478-2", "marketing_start_date": "20250130"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0478-3)", "package_ndc": "80425-0478-3", "marketing_start_date": "20250130"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (80425-0478-4)", "package_ndc": "80425-0478-4", "marketing_start_date": "20250130"}], "brand_name": "BACLOFEN", "product_id": "80425-0478_2cf6fc95-e6ff-0af3-e063-6294a90ac508", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "80425-0478", "generic_name": "BACLOFEN", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA214374", "marketing_category": "ANDA", "marketing_start_date": "20250130", "listing_expiration_date": "20261231"}