baclofen

Generic: baclofen

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-357
Product ID 76420-357_3c3b62bc-64f9-f0cb-e063-6394a90a4a92
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 76420357
Hyphenated Format 76420-357

Supplemental Identifiers

RxCUI
197391 197392 430902 2679605
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
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (76420-357-00)
  • 100 TABLET in 1 BOTTLE (76420-357-01)
  • 500 TABLET in 1 BOTTLE (76420-357-05)
  • 120 TABLET in 1 BOTTLE (76420-357-12)
  • 30 TABLET in 1 BOTTLE (76420-357-30)
  • 60 TABLET in 1 BOTTLE (76420-357-60)
  • 90 TABLET in 1 BOTTLE (76420-357-90)
source: ndc

Packages (7)

76420-357-00 1000 TABLET in 1 BOTTLE (76420-357-00) 76420-357-01 100 TABLET in 1 BOTTLE (76420-357-01) 76420-357-05 500 TABLET in 1 BOTTLE (76420-357-05) 76420-357-12 120 TABLET in 1 BOTTLE (76420-357-12) 76420-357-30 30 TABLET in 1 BOTTLE (76420-357-30) 76420-357-60 60 TABLET in 1 BOTTLE (76420-357-60) 76420-357-90 90 TABLET in 1 BOTTLE (76420-357-90)

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": "3c3b62bc-64f9-f0cb-e063-6394a90a4a92", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902", "2679605"], "spl_set_id": ["35bccefe-8d2e-85b5-e063-6394a90a58ca"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (76420-357-00)", "package_ndc": "76420-357-00", "marketing_start_date": "20250522"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-357-01)", "package_ndc": "76420-357-01", "marketing_start_date": "20250522"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-357-05)", "package_ndc": "76420-357-05", "marketing_start_date": "20250522"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (76420-357-12)", "package_ndc": "76420-357-12", "marketing_start_date": "20250813"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-357-30)", "package_ndc": "76420-357-30", "marketing_start_date": "20250522"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-357-60)", "package_ndc": "76420-357-60", "marketing_start_date": "20250522"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-357-90)", "package_ndc": "76420-357-90", "marketing_start_date": "20250522"}], "brand_name": "BACLOFEN", "product_id": "76420-357_3c3b62bc-64f9-f0cb-e063-6394a90a4a92", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "76420-357", "generic_name": "BACLOFEN", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}