Giapreza

Product NDC: 68547-501
11-digit product format: 685470501
Labeler code: 68547
Product ID: 68547-501_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: 2018-02-05
Substance: ANGIOTENSIN II
Active strength: 2.5 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 43.

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N209360-001	10335451	2029-12-16	U-2581	2019-07-26
N209360-001	10500247	2029-12-16	U-2680	2019-12-20
N209360-001	10500247	2029-12-16	U-2681	2019-12-20
N209360-001	10548943	2029-12-16	U-2739	2020-02-20
N209360-001	10548943	2029-12-16	U-2740	2020-02-20
N209360-001	9867863	2029-12-16	U-2231	2018-02-14
N209360-001	9572856	2031-07-18	U-2221	2018-01-22
N209360-001	10028995	2034-12-18	U-2338	2018-08-02
N209360-001	10493124	2034-12-18	U-2679	2019-12-20
N209360-001	11096983	2034-12-18	U-3211	2021-09-23
N209360-001	11096983	2034-12-18	U-3212	2021-09-23
N209360-001	11559559	2034-12-18	U-3514	2023-02-08
N209360-001	9220745	2034-12-18	U-2217	2018-01-22
N209360-001	9220745	2034-12-18	U-2218	2018-01-22
N209360-001	11219662	2037-01-06	U-3262	2022-01-11
N209360-002	10335451	2029-12-16	U-2581	2019-07-26
N209360-002	10500247	2029-12-16	U-2680	2019-12-20
N209360-002	10500247	2029-12-16	U-2681	2019-12-20
N209360-002	10548943	2029-12-16	U-2739	2020-02-20
N209360-002	10548943	2029-12-16	U-2740	2020-02-20
N209360-002	9867863	2029-12-16	U-2231	2018-02-14
N209360-002	9572856	2030-11-20	U-2221	2018-01-22
N209360-002	10028995	2034-12-18	U-2338	2018-08-02
N209360-002	10493124	2034-12-18	U-2679	2019-12-20
N209360-002	11096983	2034-12-18	U-3211	2021-09-23
N209360-002	11096983	2034-12-18	U-3212	2021-09-23
N209360-002	11559559	2034-12-18	U-3514	2023-02-08
N209360-002	9220745	2034-12-18	U-2217	2018-01-22
N209360-002	9220745	2034-12-18	U-2218	2018-01-22
N209360-002	11219662	2037-01-06	U-3262	2022-01-11
N209360-003	10335451	2029-12-16	U-2581	2022-01-21
N209360-003	10500247	2029-12-16	U-2680	2022-01-21
N209360-003	10500247	2029-12-16	U-2681	2022-01-21
N209360-003	10548943	2029-12-16	U-2739	2022-01-21
N209360-003	10548943	2029-12-16	U-2740	2022-01-21
N209360-003	9867863	2029-12-16	U-2231	2022-01-21
N209360-003	9572856	2031-07-18	U-2221	2022-01-21
N209360-003	10028995	2034-12-18	U-2338	2022-01-21
N209360-003	10493124	2034-12-18	U-2679	2022-01-21
N209360-003	11096983	2034-12-18	U-3211	2022-01-21
N209360-003	11096983	2034-12-18	U-3212	2022-01-21
N209360-003	11559559	2034-12-18	U-3514	2023-02-08
N209360-003	9220745	2034-12-18	U-2217	2022-01-21
N209360-003	9220745	2034-12-18	U-2218	2022-01-21
N209360-003	11219662	2037-01-06	U-3262	2022-01-11

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 3 · 120 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
2026-09-14 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209360-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209360-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209360-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209360-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209360-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209360-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 42 · 1,663 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209360-001	10335451	2029-12-16	U-2581	2019-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10500247	2029-12-16	U-2681	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10500247	2029-12-16	U-2680	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10548943	2029-12-16	U-2740	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10548943	2029-12-16	U-2739	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9867863	2029-12-16	U-2231	2018-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9572856	2031-07-18	U-2221	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10028995	2034-12-18	U-2338	2018-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10493124	2034-12-18	U-2679	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11096983	2034-12-18	U-3211	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11096983	2034-12-18	U-3212	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11559559	2034-12-18	U-3514	2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9220745	2034-12-18	U-2218	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9220745	2034-12-18	U-2217	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11219662	2037-01-06	U-3262	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10335451	2029-12-16	U-2581	2019-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10500247	2029-12-16	U-2681	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10500247	2029-12-16	U-2680	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10548943	2029-12-16	U-2740	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10548943	2029-12-16	U-2739	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9867863	2029-12-16	U-2231	2018-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9572856	2030-11-20	U-2221	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10028995	2034-12-18	U-2338	2018-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10493124	2034-12-18	U-2679	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11096983	2034-12-18	U-3211	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11096983	2034-12-18	U-3212	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11559559	2034-12-18	U-3514	2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9220745	2034-12-18	U-2217	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9220745	2034-12-18	U-2218	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11219662	2037-01-06	U-3262	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10335451	2029-12-16	U-2581	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10500247	2029-12-16	U-2681	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10500247	2029-12-16	U-2680	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10548943	2029-12-16	U-2740	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10548943	2029-12-16	U-2739	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	9867863	2029-12-16	U-2231	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	9572856	2031-07-18	U-2221	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10028995	2034-12-18	U-2338	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10493124	2034-12-18	U-2679	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	11096983	2034-12-18	U-3212	2022-01-21	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209360-001	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209360-002	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209360-003	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209360-001	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209360-002	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209360-003	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209360-001	NCE	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209360-002	NCE	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209360-003	NCE	2022-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209360-001	NCE	2022-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209360-002	NCE	2022-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209360-001	NCE	2022-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209360-002	NCE	2022-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209360-003	NCE	2022-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209360-001	NCE	2022-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209360-002	NCE	2022-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209360-001	NCE	2022-12-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209360-002	NCE	2022-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209360-001	NCE	2022-12-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209360-002	NCE	2022-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209360-001	NCE	2022-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209360-002	NCE	2022-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209360-001	NCE	2022-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209360-002	NCE	2022-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209360-001	NCE	2022-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209360-002	NCE	2022-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209360-001	NCE	2022-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209360-002	NCE	2022-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209360-001	NCE	2022-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209360-002	NCE	2022-12-21	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209360-001	NCE	2022-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209360-002	NCE	2022-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209360-003	NCE	2022-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-001	NCE	2022-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-002	NCE	2022-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-003	NCE	2022-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209360-001	NCE	2022-12-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209360-002	NCE	2022-12-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209360-003	NCE	2022-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209360-001	NCE	2022-12-21	`e64feba35796…`

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	2.5 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c265d69a-3efe-4107-9a9e-e6fd3d531c48	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
130a1d32-6dfa-469f-904c-6e21cbf0f11c	Product name	2	20260317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68547-501-02	Giapreza	1 in 1 CARTON	INJECTION	1		17
68547-501-02	Giapreza	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68547-501-02	ML - Milliliter	68547-501	cda1a128-c48f-4ac0-bbaf-79a358a2b3db	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68547-501	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giapreza	ANGIOTENSIN II	La Jolla Pharmaceutical Company	c265d69a-3efe-4107-9a9e-e6fd3d531c48	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209360 application number: NDA209360 ndc (product): 68547-501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M089EFU921	ANGIOTENSIN II	4474-91-3	ANGIOTENSIN II

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2611704	angiotensin II 0.5 MG in 1 ML Injection	PSN	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999007	angiotensin II 2.5 MG in 1 ML Injection	PSN	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611707	Giapreza 0.5 MG in 1 ML Injection	PSN	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999012	Giapreza 2.5 MG in 1 ML Injection	PSN	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611707	1 ML angiotensin II 0.5 MG/ML Injection [Giapreza]	SBD	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999012	1 ML angiotensin II 2.5 MG/ML Injection [Giapreza]	SBD	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611704	1 ML angiotensin II 0.5 MG/ML Injection	SCD	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999007	1 ML angiotensin II 2.5 MG/ML Injection	SCD	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611707	1 ML Giapreza 0.5 MG/ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999012	1 ML Giapreza 2.5 MG/ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611704	angiotensin II 0.5 MG per 1 ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999007	angiotensin II 2.5 MG per 1 ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
2611707	Giapreza 0.5 MG per 1 ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17
1999012	Giapreza 2.5 MG per 1 ML Injection	SY	c265d69a-3efe-4107-9a9e-e6fd3d531c48	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68547-501-02	68547050102	1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-02) / 1 mL in 1 VIAL, SINGLE-DOSE	2018-02-05	0000-00-00	No	No	Current
68547-501-07	68547050107	1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-07) / 1 mL in 1 VIAL, SINGLE-DOSE	2026-08-10		Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Giapreza	La Jolla Pharmaceutical Company \| Bora Pharmaceuticals Injectables Inc.	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	18