baclofen

Generic: baclofen

Labeler: palmetto pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler palmetto pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

baclofen 10 mg/5mL

Manufacturer
Palmetto Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68134-403
Product ID 68134-403_47426f2f-4630-5a83-e063-6294a90a88d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA208193
Listing Expiration 2026-12-31
Marketing Start 2024-09-25

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 68134403
Hyphenated Format 68134-403

Supplemental Identifiers

RxCUI
2667941
UPC
0368134403167
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

Packaging Origin

Original Packager
true

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 NDA208193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (68134-403-16)
source: ndc

Packages (1)

68134-403-16 473 mL in 1 BOTTLE (68134-403-16)

Ingredients (1)

baclofen (10 mg/5mL)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47426f2f-4630-5a83-e063-6294a90a88d1", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0368134403167"], "unii": ["H789N3FKE8"], "rxcui": ["2667941"], "spl_set_id": ["2422746c-afec-ad30-e063-6394a90a0403"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Palmetto Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (68134-403-16)", "package_ndc": "68134-403-16", "marketing_start_date": "20240925"}], "brand_name": "Baclofen", "product_id": "68134-403_47426f2f-4630-5a83-e063-6294a90a88d1", "dosage_form": "SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "68134-403", "generic_name": "Baclofen", "labeler_name": "Palmetto Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/5mL"}], "application_number": "NDA208193", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}