Home NDC 68547-005 Giapreza
Product NDC 68547-005
11-digit product format 685470005
Labeler code 68547
Product ID 68547-005_2c555078-770d-43d9-93e5-40e4cf5a4acf
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209360-001 GIAPREZA ANGIOTENSIN II ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 N209360-002 GIAPREZA ANGIOTENSIN II ACETATE EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 N209360-003 GIAPREZA ANGIOTENSIN II ACETATE EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209360-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 45 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209360-002 GIAPREZA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209360-003 GIAPREZA EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209360-001 GIAPREZA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 79d66fd596c7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 43 · 1,708 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 45 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-09-29 23:25 UTC 2022-09 N209360-002 NCE 2022-12-21 e64feba35796…2022-09-29 23:25 UTC 2022-09 N209360-003 NCE 2022-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209360-001 NCE 2022-12-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209360-002 NCE 2022-12-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209360-003 NCE 2022-12-21 cb3db0bc1861…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Giapreza
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANGIOTENSIN II .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M089EFU921 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1999007 Internal RxNorm lookup 1999012 Internal RxNorm lookup 2611704 Internal RxNorm lookup 2611707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68547-005-01 Giapreza 1 in 1 CARTON INJECTION 1 17 68547-005-01 Giapreza 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68547-005 GIAPREZA (ANGIOTENSIN II) INJECTION [LA JOLLA PHARMACEUTICAL COMPANY] 17 Current NDC, Legacy NDC, 2 package rows 20241127_c265d69a-3efe-4107-9a9e-e6fd3d531c48.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68547-005-01 68547000501 1 VIAL, SINGLE-DOSE in 1 CARTON (68547-005-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2022-09-15 0000-00-00 No No Current