gablofen

Generic: baclofen injection

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gablofen
Generic Name baclofen injection
Labeler piramal critical care inc
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

baclofen 500 ug/mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-155
Product ID 66794-155_3f750b1f-76d6-2f11-e063-6394a90a710d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022462
Listing Expiration 2026-12-31
Marketing Start 2017-04-01

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 66794155
Hyphenated Format 66794-155

Supplemental Identifiers

RxCUI
308517 1047437 1047440 1047444 1300890 1301627 1369783 1369784 1369787 1369788 1369791 1369792 1666613 1666615
UPC
0366794157024 0366794155020 0366794156027
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 gablofen (source: ndc)
Generic Name baclofen injection (source: ndc)
Application Number NDA022462 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 20 mL in 1 SYRINGE, GLASS (66794-155-01)
  • 20 mL in 1 VIAL, GLASS (66794-155-02)
source: ndc

Packages (2)

66794-155-01 20 mL in 1 SYRINGE, GLASS (66794-155-01) 66794-155-02 20 mL in 1 VIAL, GLASS (66794-155-02)

Ingredients (1)

baclofen (500 ug/mL)

Linked Drug Pages (1)

Gablofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "3f750b1f-76d6-2f11-e063-6394a90a710d", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0366794157024", "0366794155020", "0366794156027"], "unii": ["H789N3FKE8"], "rxcui": ["308517", "1047437", "1047440", "1047444", "1300890", "1301627", "1369783", "1369784", "1369787", "1369788", "1369791", "1369792", "1666613", "1666615"], "spl_set_id": ["00d3e846-dd92-448d-9ab8-6a07be823cc1"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 SYRINGE, GLASS (66794-155-01)", "package_ndc": "66794-155-01", "marketing_start_date": "20170401"}, {"sample": false, "description": "20 mL in 1 VIAL, GLASS (66794-155-02)", "package_ndc": "66794-155-02", "marketing_start_date": "20170401"}], "brand_name": "Gablofen", "product_id": "66794-155_3f750b1f-76d6-2f11-e063-6394a90a710d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "66794-155", "generic_name": "Baclofen Injection", "labeler_name": "Piramal Critical Care Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gablofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "500 ug/mL"}], "application_number": "NDA022462", "marketing_category": "NDA", "marketing_start_date": "20170401", "listing_expiration_date": "20261231"}