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 INJECTION
Routes
INTRATHECAL
Active Ingredients

baclofen 500 ug/mL

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-145
Product ID 72888-145_45801dc3-fb9b-c31e-e063-6294a90aff35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217324
Listing Expiration 2026-12-31
Marketing Start 2023-02-22

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 72888145
Hyphenated Format 72888-145

Supplemental Identifiers

RxCUI
308517 1300890 1666613
UPC
0372888147369 0372888146362 0372888145365
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 ANDA217324 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (72888-145-36) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

72888-145-36 1 VIAL, GLASS in 1 CARTON (72888-145-36) / 20 mL in 1 VIAL, GLASS

Ingredients (1)

baclofen (500 ug/mL)

Linked Drug Pages (1)

BACLOFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "45801dc3-fb9b-c31e-e063-6294a90aff35", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0372888147369", "0372888146362", "0372888145365"], "unii": ["H789N3FKE8"], "rxcui": ["308517", "1300890", "1666613"], "spl_set_id": ["d63af5f0-c275-480b-89b5-6cf1ad55ab63"], "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": "1 VIAL, GLASS in 1 CARTON (72888-145-36)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "72888-145-36", "marketing_start_date": "20230222"}], "brand_name": "BACLOFEN", "product_id": "72888-145_45801dc3-fb9b-c31e-e063-6294a90aff35", "dosage_form": "INJECTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "72888-145", "generic_name": "Baclofen", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BACLOFEN", "active_ingredients": [{"name": "BACLOFEN", "strength": "500 ug/mL"}], "application_number": "ANDA217324", "marketing_category": "ANDA", "marketing_start_date": "20230222", "listing_expiration_date": "20261231"}