baclofen

Generic: baclofen

Labeler: trupharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

baclofen 5 mg/1

Manufacturer
TruPharma LLC

Identifiers & Regulatory

Product NDC 52817-319
Product ID 52817-319_1645f54e-2eed-bd9b-e063-6294a90a848b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209102
Listing Expiration 2026-12-31
Marketing Start 2018-04-01

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 52817319
Hyphenated Format 52817-319

Supplemental Identifiers

RxCUI
197391 197392 430902 2679605
UPC
0352817319104 0352817320001 0352817320100 0352817321503 0352817318107 0352817321107 0352817320506 0352817321008
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 ANDA209102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (52817-319-10)
source: ndc

Packages (1)

52817-319-10 100 TABLET in 1 BOTTLE (52817-319-10)

Ingredients (1)

baclofen (5 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": "1645f54e-2eed-bd9b-e063-6294a90a848b", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0352817319104", "0352817320001", "0352817320100", "0352817321503", "0352817318107", "0352817321107", "0352817320506", "0352817321008"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902", "2679605"], "spl_set_id": ["68aa591e-ea98-4438-9a4a-4f7e9ea2b285"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["TruPharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (52817-319-10)", "package_ndc": "52817-319-10", "marketing_start_date": "20180401"}], "brand_name": "BACLOFEN", "product_id": "52817-319_1645f54e-2eed-bd9b-e063-6294a90a848b", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "52817-319", "generic_name": "BACLOFEN", "labeler_name": "TruPharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}