Baclofen injection, solution

Ingredients and appearance - Product information

Baclofen injection, solution- Baclofen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 67457-563
Route of Administration Intrathecal

Active Ingredient/Active Moiety

Ingredient Name Strength
Baclofen ( UNII: H789N3FKE8)( Baclofen - UNII: H789N3FKE8 ) 1000 ugin 1 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209594 USA

Labeler - Mylan Institutional LLC( 790384502)

Package/label principal display panel

NDC 67457-563-20

Baclofen Injection

20,000 mcg/20 mL

(1,000 mcg/mL)

For Intrathecal Use Only

Discard Unused Portion

Mylan

Rx only

Single-Dose Vial