NDC 45945-157

Gablofen

Baclofen

Gablofen is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Mallinckrodt Inc (brand Pharmaceuticals). The primary component is Baclofen.

Product ID45945-157_5b051c22-c1c9-484c-969b-1c20e07e6c05
NDC45945-157
Product TypeHuman Prescription Drug
Proprietary NameGablofen
Generic NameBaclofen
Dosage FormInjection
Route of AdministrationINTRATHECAL
Marketing Start Date2010-11-19
Marketing End Date2020-01-31
Marketing CategoryNDA / NDA
Application NumberNDA022462
Labeler NameMallinckrodt Inc (Brand Pharmaceuticals)
Substance NameBACLOFEN
Active Ingredient Strength2000 ug/mL
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 45945-157-02

20 mL in 1 VIAL, GLASS (45945-157-02)
Marketing Start Date2010-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45945-157-01 [45945015701]

Gablofen INJECTION
Marketing CategoryNDA
Application NumberNDA022462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-26
Marketing End Date2020-01-31

NDC 45945-157-02 [45945015702]

Gablofen INJECTION
Marketing CategoryNDA
Application NumberNDA022462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-19
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN2000 ug/mL

OpenFDA Data

SPL SET ID:0a50560d-d053-4cb2-8160-8ee35179c0ee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369788
  • 1666613
  • 1300890
  • 1369791
  • 1369787
  • 1047440
  • 1369792
  • 1301627
  • 1666615
  • 1047437
  • 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"

    NDCBrand NameGeneric Name
    45945-156GablofenGablofen
    45945-157GablofenGablofen
    66794-155GablofenGablofen
    66794-156GablofenGablofen
    66794-151GablofenGablofen
    66794-157GablofenGablofen
    0115-1010BaclofenBaclofen
    0115-1011BaclofenBaclofen
    0115-1012BaclofenBaclofen
    0172-4096BaclofenBaclofen
    0172-4097BaclofenBaclofen
    0527-1330Baclofenbaclofen
    0527-1333Baclofenbaclofen
    0527-1337Baclofenbaclofen
    0603-2406BaclofenBaclofen
    0603-2407BaclofenBaclofen
    0615-3541BaclofenBaclofen
    0615-3542BaclofenBaclofen
    0615-8411BaclofenBaclofen
    0615-8412BaclofenBaclofen

    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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