baclofen

Generic: baclofen

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler advagen pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-011
Product ID 72888-011_490e18d8-694e-da7b-e063-6294a90ab450
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209102
Listing Expiration 2027-12-31
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 72888011
Hyphenated Format 72888-011

Supplemental Identifiers

RxCUI
197391 197392 430902 2679605
UPC
0372888009018 0372888010007 0372888010014 0372888202051 0372888011059 0372888202013 0372888011011 0372888202303 0372888009056 0372888202006 0372888010052 0372888011004
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
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72888-011-00)
  • 100 TABLET in 1 BOTTLE (72888-011-01)
  • 500 TABLET in 1 BOTTLE (72888-011-05)
source: ndc

Packages (3)

72888-011-00 1000 TABLET in 1 BOTTLE (72888-011-00) 72888-011-01 100 TABLET in 1 BOTTLE (72888-011-01) 72888-011-05 500 TABLET in 1 BOTTLE (72888-011-05)

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": "490e18d8-694e-da7b-e063-6294a90ab450", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372888009018", "0372888010007", "0372888010014", "0372888202051", "0372888011059", "0372888202013", "0372888011011", "0372888202303", "0372888009056", "0372888202006", "0372888010052", "0372888011004"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902", "2679605"], "spl_set_id": ["04dac0f6-cc6c-4959-9bca-a6e4a99690f3"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-011-00)", "package_ndc": "72888-011-00", "marketing_start_date": "20180401"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-011-01)", "package_ndc": "72888-011-01", "marketing_start_date": "20180401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-011-05)", "package_ndc": "72888-011-05", "marketing_start_date": "20180401"}], "brand_name": "BACLOFEN", "product_id": "72888-011_490e18d8-694e-da7b-e063-6294a90ab450", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72888-011", "generic_name": "BACLOFEN", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA209102", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20271231"}