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 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-478
Product ID 72789-478_4838643b-721d-54ba-e063-6394a90ac3da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209102
Listing Expiration 2027-12-31
Marketing Start 2018-04-01

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 72789478
Hyphenated Format 72789-478

Supplemental Identifiers

RxCUI
430902
UPC
0372789478012
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 ANDA209102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-478-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-478-30)
source: ndc

Packages (2)

72789-478-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-478-01) 72789-478-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-478-30)

Ingredients (1)

baclofen (5 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": "4838643b-721d-54ba-e063-6394a90ac3da", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372789478012"], "unii": ["H789N3FKE8"], "rxcui": ["430902"], "spl_set_id": ["91175128-8285-4d04-89a9-219781be9260"], "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": "100 TABLET in 1 BOTTLE, PLASTIC (72789-478-01)", "package_ndc": "72789-478-01", "marketing_start_date": "20250121"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-478-30)", "package_ndc": "72789-478-30", "marketing_start_date": "20250828"}], "brand_name": "BACLOFEN", "product_id": "72789-478_4838643b-721d-54ba-e063-6394a90ac3da", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72789-478", "generic_name": "BACLOFEN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20271231"}