baclofen

Generic: baclofen

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-062
Product ID 83008-062_ac55cb2c-a5ac-42e1-8a2e-eb810ec7d280
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214099
Marketing Start 2024-05-21
Marketing End 2027-01-31

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 83008062
Hyphenated Format 83008-062

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 ANDA214099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (83008-062-30)
  • 90 TABLET in 1 BOTTLE (83008-062-90)
source: ndc

Packages (2)

83008-062-30 30 TABLET in 1 BOTTLE (83008-062-30) 83008-062-90 90 TABLET in 1 BOTTLE (83008-062-90)

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": "ac55cb2c-a5ac-42e1-8a2e-eb810ec7d280", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["67df80a6-7fff-496e-9a89-d43a06c2a11f"], "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 (83008-062-30)", "package_ndc": "83008-062-30", "marketing_end_date": "20261231", "marketing_start_date": "20240624"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (83008-062-90)", "package_ndc": "83008-062-90", "marketing_end_date": "20270131", "marketing_start_date": "20240521"}], "brand_name": "BACLOFEN", "product_id": "83008-062_ac55cb2c-a5ac-42e1-8a2e-eb810ec7d280", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "83008-062", "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": "ANDA214099", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20240521"}