NDC 68547-501

Giapreza

Angiotensin Ii

Giapreza is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by La Jolla Pharmaceutical Company. The primary component is Angiotensin Ii.

• Product ID: 68547-501_549816e9-ff6c-4f18-94cc-9b7a5ebe9fa7
• NDC: 68547-501
• Product Type: Human Prescription Drug
• Proprietary Name: Giapreza
• Generic Name: Angiotensin Ii
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-02-05
• Marketing Category: NDA / NDA
• Application Number: NDA209360
• Labeler Name: La Jolla Pharmaceutical Company
• Substance Name: ANGIOTENSIN II
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Vasoconstrictor [EPC],Vasoconstriction [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68547-501-02

1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-02) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68547-501-02 [68547050102]

Giapreza INJECTION

• Marketing Category: NDA
• Application Number: NDA209360
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-05

Drug Details

Active Ingredients

Ingredient	Strength
ANGIOTENSIN II	2.5 mg/mL

OpenFDA Data

• SPL SET ID: c265d69a-3efe-4107-9a9e-e6fd3d531c48
• Manufacturer:
  • La Jolla Pharmaceutical Company
• UNII:
  • M089EFU921
• RxNorm Concept Unique ID - RxCUI:
  • 1999012
  • 1999007
• UPC Code:
  • 0368547501023

Pharmacological Class

• Vasoconstrictor [EPC]
• Vasoconstriction [PE]

NDC Crossover Matching brand name "Giapreza" or generic name "Angiotensin Ii"

NDC	Brand Name	Generic Name
68547-005	Giapreza	angiotensin II
68547-501	Giapreza	angiotensin II