baclofen

Generic: baclofen

Labeler: method pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler method pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Method Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 58657-731
Product ID 58657-731_3aa113f3-27d5-328b-e063-6394a90af9e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212378
Listing Expiration 2026-12-31
Marketing Start 2024-06-15

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 58657731
Hyphenated Format 58657-731

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0358657731502 0358657732509 0358657931018 0358657732011 0358657932053 0358657731106 0358657931056 0358657930011 0358657732103 0358657731014 0358657930059 0358657730017 0358657932015 0358657730109
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 ANDA212378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (58657-731-01)
  • 1000 TABLET in 1 BOTTLE (58657-731-10)
  • 500 TABLET in 1 BOTTLE (58657-731-50)
source: ndc

Packages (3)

58657-731-01 100 TABLET in 1 BOTTLE (58657-731-01) 58657-731-10 1000 TABLET in 1 BOTTLE (58657-731-10) 58657-731-50 500 TABLET in 1 BOTTLE (58657-731-50)

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": "3aa113f3-27d5-328b-e063-6394a90af9e5", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0358657731502", "0358657732509", "0358657931018", "0358657732011", "0358657932053", "0358657731106", "0358657931056", "0358657930011", "0358657732103", "0358657731014", "0358657930059", "0358657730017", "0358657932015", "0358657730109"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["1a9db542-d2b0-141a-e063-6394a90acc11"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Method Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (58657-731-01)", "package_ndc": "58657-731-01", "marketing_start_date": "20240615"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (58657-731-10)", "package_ndc": "58657-731-10", "marketing_start_date": "20240615"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (58657-731-50)", "package_ndc": "58657-731-50", "marketing_start_date": "20240615"}], "brand_name": "Baclofen", "product_id": "58657-731_3aa113f3-27d5-328b-e063-6394a90af9e5", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "58657-731", "generic_name": "Baclofen", "labeler_name": "Method Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA212378", "marketing_category": "ANDA", "marketing_start_date": "20240615", "listing_expiration_date": "20261231"}