baclofen

Generic: baclofen

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-013
Product ID 82868-013_46dc934b-8b1e-a00e-e063-6394a90a5d4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072234
Listing Expiration 2026-12-31
Marketing Start 2023-09-27

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 82868013
Hyphenated Format 82868-013

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 ANDA072234 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-013-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (82868-013-60)
source: ndc

Packages (2)

82868-013-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-013-30) 82868-013-60 60 TABLET in 1 BOTTLE, PLASTIC (82868-013-60)

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": "46dc934b-8b1e-a00e-e063-6394a90a5d4e", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["06bcfb08-2ada-f803-e063-6394a90a826b"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-013-30)", "package_ndc": "82868-013-30", "marketing_start_date": "20231114"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (82868-013-60)", "package_ndc": "82868-013-60", "marketing_start_date": "20230927"}], "brand_name": "Baclofen", "product_id": "82868-013_46dc934b-8b1e-a00e-e063-6394a90a5d4e", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "82868-013", "generic_name": "Baclofen", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA072234", "marketing_category": "ANDA", "marketing_start_date": "20230927", "listing_expiration_date": "20261231"}