baclofen

Generic: baclofen

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

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler advagen pharma ltd
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

baclofen 5 mg/5mL

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-103
Product ID 72888-103_3760a935-7c14-5771-e063-6394a90a1fb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214445
Listing Expiration 2026-12-31
Marketing Start 2024-12-06

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 72888103
Hyphenated Format 72888-103

Supplemental Identifiers

RxCUI
250976
UPC
0372888103242
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 ANDA214445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (72888-103-24)
source: ndc

Packages (1)

72888-103-24 473 mL in 1 BOTTLE (72888-103-24)

Ingredients (1)

baclofen (5 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": "3760a935-7c14-5771-e063-6394a90a1fb0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372888103242"], "unii": ["H789N3FKE8"], "rxcui": ["250976"], "spl_set_id": ["2a43830f-a28b-ca15-e063-6294a90a6b1a"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (72888-103-24)", "package_ndc": "72888-103-24", "marketing_start_date": "20241206"}], "brand_name": "BACLOFEN", "product_id": "72888-103_3760a935-7c14-5771-e063-6394a90a1fb0", "dosage_form": "SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72888-103", "generic_name": "Baclofen", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "5 mg/5mL"}], "application_number": "ANDA214445", "marketing_category": "ANDA", "marketing_start_date": "20241206", "listing_expiration_date": "20261231"}