baclofen

Generic: baclofen

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2081
Product ID 63629-2081_8a1480d9-122f-4064-a751-0f29f0b72c47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078220
Listing Expiration 2026-12-31
Marketing Start 2007-07-01

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 636292081
Hyphenated Format 63629-2081

Supplemental Identifiers

RxCUI
197391
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 ANDA078220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (63629-2081-1)
source: ndc

Packages (1)

63629-2081-1 1000 TABLET in 1 BOTTLE (63629-2081-1)

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": "8a1480d9-122f-4064-a751-0f29f0b72c47", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["402a0a2b-95a6-4d22-bedf-826e1f1cd2c3"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (63629-2081-1)", "package_ndc": "63629-2081-1", "marketing_start_date": "20070701"}], "brand_name": "Baclofen", "product_id": "63629-2081_8a1480d9-122f-4064-a751-0f29f0b72c47", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "63629-2081", "generic_name": "baclofen", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA078220", "marketing_category": "ANDA", "marketing_start_date": "20070701", "listing_expiration_date": "20261231"}