Hydralazine hydrochloride injection, solution

Ingredients and appearance - Product information

Hydralazine hydrochloride injection, solution- Hydralazine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0517-0901
Route of Administration Intramuscular

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydralazine hydrochloride ( UNII: FD171B778Y)( Hydralazine - UNII: 26NAK24LS8 ) 20 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Propylene glycol ( UNII: 6DC9Q167V3)
Methylparaben ( UNII: A2I8C7HI9T)
Propylparaben ( UNII: Z8IX2SC1OH)
Hydrochloric acid ( UNII: QTT17582CB)
Sodium hydroxide ( UNII: 55X04QC32I)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040136 USA

Labeler - American Regent, Inc.( 002033710)

Establishment

Name ID/FEI Business Operations
American Regent, Inc. 002033710 ANALYSIS( 0517-0901), MANUFACTURE( 0517-0901), STERILIZE( 0517-0901)