baclofen

Generic: baclofen

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-565
Product ID 72189-565_1bf59c3b-f8ec-972e-e063-6394a90aeccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214374
Listing Expiration 2026-12-31
Marketing Start 2024-06-28

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 72189565
Hyphenated Format 72189-565

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 ANDA214374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-565-60)
  • 180 TABLET in 1 BOTTLE (72189-565-82)
  • 90 TABLET in 1 BOTTLE (72189-565-90)
source: ndc

Packages (3)

72189-565-60 60 TABLET in 1 BOTTLE (72189-565-60) 72189-565-82 180 TABLET in 1 BOTTLE (72189-565-82) 72189-565-90 90 TABLET in 1 BOTTLE (72189-565-90)

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": "1bf59c3b-f8ec-972e-e063-6394a90aeccc", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["1bf59c3b-f8eb-972e-e063-6394a90aeccc"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-565-60)", "package_ndc": "72189-565-60", "marketing_start_date": "20240628"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (72189-565-82)", "package_ndc": "72189-565-82", "marketing_start_date": "20240628"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-565-90)", "package_ndc": "72189-565-90", "marketing_start_date": "20240628"}], "brand_name": "Baclofen", "product_id": "72189-565_1bf59c3b-f8ec-972e-e063-6394a90aeccc", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72189-565", "generic_name": "Baclofen", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA214374", "marketing_category": "ANDA", "marketing_start_date": "20240628", "listing_expiration_date": "20261231"}