BACLOFEN

Generic: BACLOFEN

Labeler: Quality Care Products, LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name BACLOFEN
Generic Name BACLOFEN
Labeler Quality Care Products, LLC
Dosage Form TABLET
Routes
ORAL
Active Ingredients

BACLOFEN 20 mg/1

Identifiers & Regulatory

Product NDC 83008-018
Product ID 83008-018_789f1c96-bd7f-4eda-b0e2-1a598b4a5914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214374
Marketing Start 2023-04-25
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008018
Hyphenated Format 83008-018

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 (83008-018-30)
  • 60 TABLET in 1 BOTTLE (83008-018-60)
  • 90 TABLET in 1 BOTTLE (83008-018-90)
source: ndc

Packages (3)

83008-018-30 30 TABLET in 1 BOTTLE (83008-018-30) 83008-018-60 60 TABLET in 1 BOTTLE (83008-018-60) 83008-018-90 90 TABLET in 1 BOTTLE (83008-018-90)

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": "789f1c96-bd7f-4eda-b0e2-1a598b4a5914", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["22477d77-3369-43cf-a444-dfc7ea69cacf"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (83008-018-30)", "package_ndc": "83008-018-30", "marketing_end_date": "20260228", "marketing_start_date": "20230425"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (83008-018-60)", "package_ndc": "83008-018-60", "marketing_end_date": "20260228", "marketing_start_date": "20230425"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (83008-018-90)", "package_ndc": "83008-018-90", "marketing_end_date": "20260228", "marketing_start_date": "20230425"}], "brand_name": "BACLOFEN", "product_id": "83008-018_789f1c96-bd7f-4eda-b0e2-1a598b4a5914", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "83008-018", "generic_name": "BACLOFEN", "labeler_name": "Quality Care Products, 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_end_date": "20260228", "marketing_start_date": "20230425"}