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 ID: 45945-157_5b051c22-c1c9-484c-969b-1c20e07e6c05
• NDC: 45945-157
• Product Type: Human Prescription Drug
• Proprietary Name: Gablofen
• Generic Name: Baclofen
• Dosage Form: Injection
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2010-11-19
• Marketing End Date: 2020-01-31
• Marketing Category: NDA / NDA
• Application Number: NDA022462
• Labeler Name: Mallinckrodt Inc (Brand Pharmaceuticals)
• Substance Name: BACLOFEN
• Active Ingredient Strength: 2000 ug/mL
• Pharm Classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 45945-157-02

20 mL in 1 VIAL, GLASS (45945-157-02)

• Marketing Start Date: 2010-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45945-157-01 [45945015701]

Gablofen INJECTION

• Marketing Category: NDA
• Application Number: NDA022462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-03-26
• Marketing End Date: 2020-01-31

NDC 45945-157-02 [45945015702]

Gablofen INJECTION

• Marketing Category: NDA
• Application Number: NDA022462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-19
• Marketing End Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BACLOFEN	2000 ug/mL

OpenFDA Data

• SPL SET ID: 0a50560d-d053-4cb2-8160-8ee35179c0ee
• Manufacturer:
  • Mallinckrodt Inc (Brand Pharmaceuticals)
• UNII:
  • H789N3FKE8
• 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"

NDC	Brand Name	Generic Name
45945-156	Gablofen	Gablofen
45945-157	Gablofen	Gablofen
66794-155	Gablofen	Gablofen
66794-156	Gablofen	Gablofen
66794-151	Gablofen	Gablofen
66794-157	Gablofen	Gablofen
0115-1010	Baclofen	Baclofen
0115-1011	Baclofen	Baclofen
0115-1012	Baclofen	Baclofen
0172-4096	Baclofen	Baclofen
0172-4097	Baclofen	Baclofen
0527-1330	Baclofen	baclofen
0527-1333	Baclofen	baclofen
0527-1337	Baclofen	baclofen
0603-2406	Baclofen	Baclofen
0603-2407	Baclofen	Baclofen
0615-3541	Baclofen	Baclofen
0615-3542	Baclofen	Baclofen
0615-8411	Baclofen	Baclofen
0615-8412	Baclofen	Baclofen