baclofen

Generic: baclofen

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

baclofen 10 mg/5mL

Manufacturer
TRUPHARMA, LLC

Identifiers & Regulatory

Product NDC 52817-620
Product ID 52817-620_0806a6f9-b626-f98e-e063-6294a90a84bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA208193
Listing Expiration 2026-12-31
Marketing Start 2023-10-12

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 52817620
Hyphenated Format 52817-620

Supplemental Identifiers

RxCUI
2667941
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 NDA208193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (52817-620-08)
source: ndc

Packages (1)

52817-620-08 237 mL in 1 BOTTLE (52817-620-08)

Ingredients (1)

baclofen (10 mg/5mL)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0806a6f9-b626-f98e-e063-6294a90a84bb", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["2667941"], "spl_set_id": ["f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7"], "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": "237 mL in 1 BOTTLE (52817-620-08)", "package_ndc": "52817-620-08", "marketing_start_date": "20231012"}], "brand_name": "Baclofen", "product_id": "52817-620_0806a6f9-b626-f98e-e063-6294a90a84bb", "dosage_form": "SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "52817-620", "generic_name": "Baclofen", "labeler_name": "TRUPHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/5mL"}], "application_number": "NDA208193", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231012", "listing_expiration_date": "20261231"}