baclofen

Generic: baclofen

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8518
Product ID 0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215885
Listing Expiration 2026-12-31
Marketing Start 2022-01-26

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 06158518
Hyphenated Format 0615-8518

Supplemental Identifiers

RxCUI
430902
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 ANDA215885 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8518-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8518-39)
source: ndc

Packages (2)

0615-8518-05 15 TABLET in 1 BLISTER PACK (0615-8518-05) 0615-8518-39 30 TABLET in 1 BLISTER PACK (0615-8518-39)

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": "8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["430902"], "spl_set_id": ["ea4ad5c5-207c-4a68-8e6e-4ff101777e5c"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8518-05)", "package_ndc": "0615-8518-05", "marketing_start_date": "20240814"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8518-39)", "package_ndc": "0615-8518-39", "marketing_start_date": "20240814"}], "brand_name": "Baclofen", "product_id": "0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "0615-8518", "generic_name": "Baclofen", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/1"}], "application_number": "ANDA215885", "marketing_category": "ANDA", "marketing_start_date": "20220126", "listing_expiration_date": "20261231"}