Giapreza

Product NDC
68547-005
11-digit product format
685470005
Labeler code
68547
Product ID
68547-005_49438c9b-3fce-4f3b-b878-18a17bc62b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
angiotensin II
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
La Jolla Pharmaceutical Company
Application
NDA209360
Marketing category
NDA
Marketing start
2022-09-15
Substance
ANGIOTENSIN II
Active strength
.5 mg/mL
Pharmacologic classes
Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Giapreza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGIOTENSIN II.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM089EFU921
Rxcui1999007, 1999012, 2611704, 2611707

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
130a1d32-6dfa-469f-904c-6e21cbf0f11cProduct name220260317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68547-005-01Giapreza1 in 1 CARTONINJECTION117
68547-005-01Giapreza1 mL in 1 VIAL, SINGLE-DOSEINJECTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68547-005-01ML - Milliliter68547-00522b9686f-fbf3-4c0c-85af-9f4b622f89fe12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68547-005GIAPREZA (ANGIOTENSIN II) INJECTION [LA JOLLA PHARMACEUTICAL COMPANY]17Current NDC, Legacy NDC, 2 package rows20241127_c265d69a-3efe-4107-9a9e-e6fd3d531c48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2611704angiotensin II 0.5 MG in 1 ML InjectionPSNc265d69a-3efe-4107-9a9e-e6fd3d531c4817
1999007angiotensin II 2.5 MG in 1 ML InjectionPSNc265d69a-3efe-4107-9a9e-e6fd3d531c4817
2611707Giapreza 0.5 MG in 1 ML InjectionPSNc265d69a-3efe-4107-9a9e-e6fd3d531c4817
1999012Giapreza 2.5 MG in 1 ML InjectionPSNc265d69a-3efe-4107-9a9e-e6fd3d531c4817
26117071 ML angiotensin II 0.5 MG/ML Injection [Giapreza]SBDc265d69a-3efe-4107-9a9e-e6fd3d531c4817
19990121 ML angiotensin II 2.5 MG/ML Injection [Giapreza]SBDc265d69a-3efe-4107-9a9e-e6fd3d531c4817
26117041 ML angiotensin II 0.5 MG/ML InjectionSCDc265d69a-3efe-4107-9a9e-e6fd3d531c4817
19990071 ML angiotensin II 2.5 MG/ML InjectionSCDc265d69a-3efe-4107-9a9e-e6fd3d531c4817
26117071 ML Giapreza 0.5 MG/ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817
19990121 ML Giapreza 2.5 MG/ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817
2611704angiotensin II 0.5 MG per 1 ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817
1999007angiotensin II 2.5 MG per 1 ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817
2611707Giapreza 0.5 MG per 1 ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817
1999012Giapreza 2.5 MG per 1 ML InjectionSYc265d69a-3efe-4107-9a9e-e6fd3d531c4817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68547-005-01685470005011 VIAL, SINGLE-DOSE in 1 CARTON (68547-005-01) / 1 mL in 1 VIAL, SINGLE-DOSE2022-09-150000-00-00NoNoCurrent