Application 019734

Type: NDA
Sponsor: CHIESI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDENE	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	20MG/200ML (0.1MG/ML)	Yes	Yes
003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	20MG/200ML (0.1MG/ML)	Yes	Yes
004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	40MG/200ML (0.2MG/ML)	Yes	Yes
005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	40MG/200ML (0.2MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019734-001	CARDENE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1992-01-30
N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31
N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31
N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07
N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019734-001	AP
N019734-003	AP
N019734-004	AP

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N019734-002	10758616	2027-04-18		Drug product	2020-09-29
N019734-002	11547758	2027-04-18	U-1029		2023-02-09
N019734-002	7659291	2027-04-18	U-1029
N019734-002	8455524	2027-04-18	U-1029		2013-06-27
N019734-002	7612102	2027-12-26		Drug product
N019734-002	9364564	2027-12-26		Drug product	2016-07-08
N019734-003	10758616	2027-04-18		Drug product	2020-09-29
N019734-003	11547758	2027-04-18	U-1029		2023-02-09
N019734-003	7659291	2027-04-18	U-1029
N019734-003	8455524	2027-04-18	U-1029
N019734-003	7612102	2027-12-26		Drug product
N019734-003	9364564	2027-12-26		Drug product	2016-07-08
N019734-004	10758616	2027-04-18		Drug product	2020-09-29
N019734-004	11547758	2027-04-18	U-1029		2023-02-09
N019734-004	7659291	2027-04-18	U-1029
N019734-004	8455524	2027-04-18	U-1029
N019734-004	7612102	2027-12-26		Drug product
N019734-004	9364564	2027-12-26		Drug product	2016-07-08
N019734-005	7659291	2027-04-18	U-1029
N019734-005	8455524	2027-04-18	U-1029
N019734-005	7612102	2027-12-26		Drug product
N019734-005	9364564	2027-12-26		Drug product	2016-07-08

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 6 · 210 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	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1992-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1992-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-001	CARDENE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`2680178bc6a6…`

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	N019734-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019734-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019734-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019734-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019734-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019734-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019734-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019734-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019734-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019734-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019734-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019734-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019734-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019734-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019734-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019734-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019734-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019734-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019734-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019734-004	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019734-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019734-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019734-004	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 858 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019734-002	10758616	2027-04-18		Drug product	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	11547758	2027-04-18	U-1029		2023-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	7659291	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	8455524	2027-04-18	U-1029		2013-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	7612102	2027-12-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-002	9364564	2027-12-26		Drug product	2016-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	10758616	2027-04-18		Drug product	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	11547758	2027-04-18	U-1029		2023-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	7659291	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	8455524	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	7612102	2027-12-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-003	9364564	2027-12-26		Drug product	2016-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	10758616	2027-04-18		Drug product	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	11547758	2027-04-18	U-1029		2023-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	7659291	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	8455524	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	7612102	2027-12-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-004	9364564	2027-12-26		Drug product	2016-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-005	7659291	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-005	8455524	2027-04-18	U-1029			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-005	7612102	2027-12-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019734-005	9364564	2027-12-26		Drug product	2016-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019734-002	10758616	2027-04-18		Drug product	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	11547758	2027-04-18	U-1029		2023-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	7659291	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	8455524	2027-04-18	U-1029		2013-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	7612102	2027-12-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-002	9364564	2027-12-26		Drug product	2016-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	10758616	2027-04-18		Drug product	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	11547758	2027-04-18	U-1029		2023-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	7659291	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	8455524	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	7612102	2027-12-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-003	9364564	2027-12-26		Drug product	2016-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	10758616	2027-04-18		Drug product	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	11547758	2027-04-18	U-1029		2023-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	7659291	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	8455524	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	7612102	2027-12-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-004	9364564	2027-12-26		Drug product	2016-07-08	`011fe1cb6892…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	a3e33add-0d09-423a-9109-42e5ba7148d5	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019734 application number: NDA019734 ndc (product): 43066-026 ndc (product): 43066-028
Cardene IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	5499cfac-9147-4d5d-a8cb-f8d64f1481af	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019734 application number: NDA019734 ndc (product): 43066-024 ndc (product): 43066-021
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019734 application number: NDA019734 ndc (product): 43066-016 ndc (product): 43066-009
CARDENE IV	NICARDIPINE HYDROCHLORIDE	Baxter Healthcare Corporation	5749599d-ff2a-42e4-aa72-cd25013feee8	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019734 application number: NDA019734

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-313	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-313	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-314	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-314	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-325	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-325	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
51662-1428	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85594	SUPPL	2026-03-31
85577	SUPPL	2026-03-30
81367	SUPPL	2025-02-25
81354	SUPPL	2025-02-25
72132	SUPPL	2022-09-21
72104	SUPPL	2022-09-19
57353	SUPPL	2019-01-28
55048	SUPPL	2018-07-30
45172	SUPPL	2016-08-26
45068	SUPPL	2016-08-26
11665	SUPPL	2014-07-24
1559	SUPPL	2014-07-24
1558	SUPPL	2011-02-09
33895	SUPPL	2011-02-07
33894	SUPPL	2010-01-20
19133	SUPPL	2010-01-15
1557	SUPPL	2008-11-13
62317	SUPPL	2008-11-07
1556	SUPPL	2008-08-05
62316	SUPPL	2008-07-31
19132	SUPPL	2007-07-05