baclofen

Generic: baclofen

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4349
Product ID 55154-4349_fde98469-5aee-4002-8dd4-e75f1d2b89e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211659
Listing Expiration 2026-12-31
Marketing Start 2024-11-22

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 551544349
Hyphenated Format 55154-4349

Supplemental Identifiers

RxCUI
430902
UPC
0055154434904
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 ANDA211659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-4349-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-4349-0 10 BLISTER PACK in 1 BAG (55154-4349-0) / 1 TABLET in 1 BLISTER PACK

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": "fde98469-5aee-4002-8dd4-e75f1d2b89e1", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0055154434904"], "unii": ["H789N3FKE8"], "rxcui": ["430902"], "spl_set_id": ["3c87e116-871d-46b8-897b-fc27a17b988d"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-4349-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-4349-0", "marketing_start_date": "20241122"}], "brand_name": "Baclofen", "product_id": "55154-4349_fde98469-5aee-4002-8dd4-e75f1d2b89e1", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "55154-4349", "generic_name": "Baclofen", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA211659", "marketing_category": "ANDA", "marketing_start_date": "20241122", "listing_expiration_date": "20261231"}