REDIENTS AND APPEARANCE
GIAPREZA
angiotensin ii injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68547-501
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
angiotensin II (UNII: M089EFU921) (angiotensin II - UNII:M089EFU921) angiotensin II 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
mannitol (UNII: 3OWL53L36A) 25 mg in 1 mL
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
hydrochloric acid (UNII: QTT17582CB)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:68547-501-02 1 in 1 CARTON 02/05/2018
1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA209360 02/05/2018
Labeler - La Jolla Pharmaceutical Company (613541192)
Establishment
Name
Address
ID/FEI
Business Operations
PolyPeptide Laboratories, San Diego 621516145 API MANUFACTURE(68547-501) , ANALYSIS(68547-501)
Establishment
Name
Address
ID/FEI
Business Operations
PPD Development, LP. 838082055 ANALYSIS(68547-501)
Establishment
Name
Address
ID/FEI
Business Operations
Exova, Inc. 029170432 ANALYSIS(68547-501)
Establishment
Name
Address
ID/FEI
Business Operations
BioScreen Testing Services, Inc. 177127834 ANALYSIS(68547-501)
Establishment
Name
Address
ID/FEI
Business Operations
AndersonBrecon, Inc. dba PCI Pharma Services 053217022 PACK(68547-501) , LABEL(68547-501)
Establishment
Name
Address
ID/FEI
Business Operations
Packaging Coordinators, LLC 078525133 PACK(68547-501) , LABEL(68547-501)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c265d69a-3efe-4107-9a9e-e6fd3d531c48
