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 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-312
Product ID 72789-312_40bb0acb-4bbf-f606-e063-6294a90a07d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209102
Listing Expiration 2026-12-31
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 72789312
Hyphenated Format 72789-312

Supplemental Identifiers

RxCUI
197392
UPC
0372789312903
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
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-312-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-312-90)
source: ndc

Packages (2)

72789-312-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-312-30) 72789-312-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-312-90)

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": "40bb0acb-4bbf-f606-e063-6294a90a07d0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372789312903"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["5cba5255-e5ad-48fd-8385-60e9ea6b6407"], "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 (72789-312-30)", "package_ndc": "72789-312-30", "marketing_start_date": "20230315"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-312-90)", "package_ndc": "72789-312-90", "marketing_start_date": "20230425"}], "brand_name": "BACLOFEN", "product_id": "72789-312_40bb0acb-4bbf-f606-e063-6294a90a07d0", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72789-312", "generic_name": "BACLOFEN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}