baclofen

Generic: baclofen

Labeler: hawaii repack, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler hawaii repack, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
HAWAII REPACK, INC.

Identifiers & Regulatory

Product NDC 85534-0004
Product ID 85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214099
Listing Expiration 2026-12-31
Marketing Start 2021-07-13

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 855340004
Hyphenated Format 85534-0004

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 ANDA214099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (85534-0004-0)
  • 120 TABLET in 1 BOTTLE (85534-0004-1)
  • 30 TABLET in 1 BOTTLE (85534-0004-3)
  • 60 TABLET in 1 BOTTLE (85534-0004-6)
  • 90 TABLET in 1 BOTTLE (85534-0004-9)
source: ndc

Packages (5)

85534-0004-0 100 TABLET in 1 BOTTLE (85534-0004-0) 85534-0004-1 120 TABLET in 1 BOTTLE (85534-0004-1) 85534-0004-3 30 TABLET in 1 BOTTLE (85534-0004-3) 85534-0004-6 60 TABLET in 1 BOTTLE (85534-0004-6) 85534-0004-9 90 TABLET in 1 BOTTLE (85534-0004-9)

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": "37457bd5-2fd0-b829-e063-6294a90a04f0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197392"], "spl_set_id": ["bc48a775-1feb-44c4-9453-e1ccf3d929bd"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["HAWAII REPACK, INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (85534-0004-0)", "package_ndc": "85534-0004-0", "marketing_start_date": "20250611"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (85534-0004-1)", "package_ndc": "85534-0004-1", "marketing_start_date": "20250611"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85534-0004-3)", "package_ndc": "85534-0004-3", "marketing_start_date": "20250611"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85534-0004-6)", "package_ndc": "85534-0004-6", "marketing_start_date": "20250611"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85534-0004-9)", "package_ndc": "85534-0004-9", "marketing_start_date": "20250611"}], "brand_name": "BACLOFEN", "product_id": "85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "85534-0004", "generic_name": "BACLOFEN", "labeler_name": "HAWAII REPACK, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA214099", "marketing_category": "ANDA", "marketing_start_date": "20210713", "listing_expiration_date": "20261231"}