baclofen

Generic: baclofen

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

baclofen 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7553
Product ID 0904-7553_5c3857ec-f6de-489c-909d-79cad21f784e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215885
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

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 09047553
Hyphenated Format 0904-7553

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 ANDA215885 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0904-7553-61) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7553-61 10 BLISTER PACK in 1 CARTON (0904-7553-61) / 10 TABLET in 1 BLISTER PACK

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": "5c3857ec-f6de-489c-909d-79cad21f784e", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392"], "spl_set_id": ["f328296e-0713-4acb-bcb5-c10d7838d380"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0904-7553-61)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7553-61", "marketing_start_date": "20251101"}], "brand_name": "BACLOFEN", "product_id": "0904-7553_5c3857ec-f6de-489c-909d-79cad21f784e", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "0904-7553", "generic_name": "baclofen", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA215885", "marketing_category": "ANDA", "marketing_start_date": "20251101", "listing_expiration_date": "20261231"}