Application 090534

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/10ML (2.5MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090534-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090534-001	AP

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		RS	2009-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090534-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090534-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090534-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090534-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090534-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090534-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090534-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090534-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090534-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090534-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090534-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090534-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090534-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090534-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090534-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090534-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090534-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090534-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090534-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090534-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090534-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090534-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090534-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090534-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090534-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090534-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090534-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090534-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090534-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090534-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090534-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090534-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090534-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090534-001	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	American Regent, Inc.	76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090534 application number: ANDA090534 ndc (product): 0517-0735
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Civica, Inc.	30fb3a4d-fa75-42fd-b4b6-2a21f202027f	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090534 application number: ANDA090534 ndc (product): 72572-470

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0735	Nicardipine Hydrochloride	nicardipine hydrochloride	American Regent, Inc.	ANDA	Current
0517-0735	Nicardipine Hydrochloride	nicardipine hydrochloride	American Regent, Inc.	ANDA	Current
0517-0735	Nicardipine Hydrochloride	nicardipine hydrochloride	American Regent, Inc.	ANDA	Current
0517-0735	Nicardipine Hydrochloride	nicardipine hydrochloride	American Regent, Inc.	ANDA	Current
40042-047	Nicardipine Hydrochloride	Nicardipine Hydrochloride	PharmaForce, Inc.	ANDA	Current
72572-470	Nicardipine Hydrochloride	nicardipine hydrochloride	Civica, Inc.	ANDA	Current