baclofen

Generic: baclofen

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1055
Product ID 0832-1055_45af8926-ad18-a93a-e063-6294a90a1dca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074584
Marketing Start 2010-10-20
Marketing End 2026-09-30

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 08321055
Hyphenated Format 0832-1055

Supplemental Identifiers

RxCUI
197391 197392
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 ANDA074584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (0832-1055-10)
  • 500 TABLET in 1 BOTTLE (0832-1055-15)
  • 90 TABLET in 1 BOTTLE (0832-1055-90)
source: ndc

Packages (3)

0832-1055-10 1000 TABLET in 1 BOTTLE (0832-1055-10) 0832-1055-15 500 TABLET in 1 BOTTLE (0832-1055-15) 0832-1055-90 90 TABLET in 1 BOTTLE (0832-1055-90)

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": "45af8926-ad18-a93a-e063-6294a90a1dca", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392"], "spl_set_id": ["b2747a9d-5fca-4657-9e4b-4112607f30d8"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (0832-1055-10)", "package_ndc": "0832-1055-10", "marketing_end_date": "20260930", "marketing_start_date": "20180227"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0832-1055-15)", "package_ndc": "0832-1055-15", "marketing_end_date": "20260930", "marketing_start_date": "20180227"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0832-1055-90)", "package_ndc": "0832-1055-90", "marketing_end_date": "20260930", "marketing_start_date": "20180227"}], "brand_name": "Baclofen", "product_id": "0832-1055_45af8926-ad18-a93a-e063-6294a90a1dca", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "0832-1055", "generic_name": "Baclofen", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA074584", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20101020"}