baclofen

Generic: baclofen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-757
Product ID 55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072234
Listing Expiration 2026-12-31
Marketing Start 1988-07-21

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 55289757
Hyphenated Format 55289-757

Supplemental Identifiers

RxCUI
197391
UPC
0355289757306
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 ANDA072234 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)
source: ndc

Packages (3)

55289-757-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30) 55289-757-60 60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60) 55289-757-90 90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)

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": "419b4e87-cb86-8fbc-e063-6394a90a3b7c", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0355289757306"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["95755a7b-4a9f-45ea-a381-d3f661150efe"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30)", "package_ndc": "55289-757-30", "marketing_start_date": "20090324"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60)", "package_ndc": "55289-757-60", "marketing_start_date": "20090324"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)", "package_ndc": "55289-757-90", "marketing_start_date": "20071226"}], "brand_name": "Baclofen", "product_id": "55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "55289-757", "generic_name": "Baclofen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA072234", "marketing_category": "ANDA", "marketing_start_date": "19880721", "listing_expiration_date": "20261231"}