baclofen

Generic: baclofen

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4682
Product ID 50090-4682_0825b008-5a6d-4ad7-8cdb-73ebb6692302
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211659
Listing Expiration 2027-12-31
Marketing Start 2018-12-06

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 500904682
Hyphenated Format 50090-4682

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 ANDA211659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (50090-4682-0)
  • 60 TABLET in 1 BOTTLE (50090-4682-1)
  • 30 TABLET in 1 BOTTLE (50090-4682-2)
  • 90 TABLET in 1 BOTTLE (50090-4682-3)
source: ndc

Packages (4)

50090-4682-0 20 TABLET in 1 BOTTLE (50090-4682-0) 50090-4682-1 60 TABLET in 1 BOTTLE (50090-4682-1) 50090-4682-2 30 TABLET in 1 BOTTLE (50090-4682-2) 50090-4682-3 90 TABLET in 1 BOTTLE (50090-4682-3)

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": "0825b008-5a6d-4ad7-8cdb-73ebb6692302", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["975fda6d-d929-482b-8be7-60849026dbdd"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (50090-4682-0)", "package_ndc": "50090-4682-0", "marketing_start_date": "20191104"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-4682-1)", "package_ndc": "50090-4682-1", "marketing_start_date": "20191104"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-4682-2)", "package_ndc": "50090-4682-2", "marketing_start_date": "20191104"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-4682-3)", "package_ndc": "50090-4682-3", "marketing_start_date": "20191104"}], "brand_name": "Baclofen", "product_id": "50090-4682_0825b008-5a6d-4ad7-8cdb-73ebb6692302", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "50090-4682", "generic_name": "Baclofen", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA211659", "marketing_category": "ANDA", "marketing_start_date": "20181206", "listing_expiration_date": "20271231"}