NDC 66794-156

Gablofen

Baclofen Injection

Gablofen is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Piramal Critical Care Inc. The primary component is Baclofen.

Product ID66794-156_63af2eb8-696f-907b-e053-2991aa0a7c08
NDC66794-156
Product TypeHuman Prescription Drug
Proprietary NameGablofen
Generic NameBaclofen Injection
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL
Marketing Start Date2017-04-01
Marketing CategoryNDA / NDA
Application NumberNDA022462
Labeler NamePiramal Critical Care Inc
Substance NameBACLOFEN
Active Ingredient Strength1000 ug/mL
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66794-156-01

20 mL in 1 SYRINGE, GLASS (66794-156-01)
Marketing Start Date2017-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66794-156-02 [66794015602]

Gablofen INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-04-01

NDC 66794-156-01 [66794015601]

Gablofen INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-04-01

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN1000 ug/mL

OpenFDA Data

SPL SET ID:00d3e846-dd92-448d-9ab8-6a07be823cc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369791
  • 1369788
  • 1666613
  • 1300890
  • 1369783
  • 1047444
  • 1369784
  • 1369787
  • 1047440
  • 1369792
  • 1301627
  • 1666615
  • 1047437
  • 308517
  • Pharmacological Class

    • GABA A Agonists [MoA]
    • GABA B Agonists [MoA]
    • gamma-Aminobutyric Acid-ergic Agonist [EPC]

    NDC Crossover Matching brand name "Gablofen" or generic name "Baclofen Injection"

    NDCBrand NameGeneric Name
    45945-156Gablofenbaclofen
    45945-157Gablofenbaclofen
    66794-151GablofenBaclofen Injection
    66794-155GablofenBaclofen Injection
    66794-156GablofenBaclofen Injection
    66794-157GablofenBaclofen Injection

    Trademark Results [Gablofen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GABLOFEN
    GABLOFEN
    85457562 not registered Dead/Abandoned
    CNS Therapeutics, Inc.
    2011-10-27
    GABLOFEN
    GABLOFEN
    77850392 4122201 Live/Registered
    PIRAMAL CRITICAL CARE, INC.
    2009-10-16

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