CARDENE IV

Product NDC: 43066-016
11-digit product format: 430660016
Labeler code: 43066
Product ID: 43066-016_29b8dd22-cb60-44ee-b715-3f185a1118a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicardipine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA019734
Marketing category: NDA
Marketing start: 1992-01-30
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: .2 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 1.

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NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1992-01-30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 · 205 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
2026-02-19 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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 21 · 836 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N019734-005	7659291	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-005	8455524	2027-04-18	U-1029			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-005	7612102	2027-12-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019734-005	9364564	2027-12-26		Drug product	2016-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	10758616	2027-04-18		Drug product	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	11547758	2027-04-18	U-1029		2023-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	7659291	2027-04-18	U-1029			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	8455524	2027-04-18	U-1029		2013-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	7612102	2027-12-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-002	9364564	2027-12-26		Drug product	2016-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	10758616	2027-04-18		Drug product	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	11547758	2027-04-18	U-1029		2023-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	7659291	2027-04-18	U-1029			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	8455524	2027-04-18	U-1029			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	7612102	2027-12-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-003	9364564	2027-12-26		Drug product	2016-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	10758616	2027-04-18		Drug product	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	11547758	2027-04-18	U-1029		2023-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	7659291	2027-04-18	U-1029			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	8455524	2027-04-18	U-1029			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	7612102	2027-12-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019734-004	9364564	2027-12-26		Drug product	2016-07-08	`31067a03dcf5…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: CARDENE IV
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICARDIPINE HYDROCHLORIDE	.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K5BC5011K3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858599	Internal RxNorm lookup
858601	Internal RxNorm lookup
858603	Internal RxNorm lookup
858605	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
f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
31746078-c5c3-4387-a2ed-bd3c8b244c53	Product name	2	20250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03	Product name	2	20250203
c9eb0343-053f-7f78-730f-1be02ab91c6c	Product name	5	20250130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43066-016-10	CARDENE IV	10 in 1 CARTON	INJECTION, SOLUTION	10		18
43066-016-10	CARDENE IV	200 mL in 1 BAG	INJECTION, SOLUTION	200		18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43066-016	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	16	Current NDC, Legacy NDC, 2 package rows	20250303_f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K5BC5011K3	NICARDIPINE HYDROCHLORIDE	54527-84-3	NICARDIPINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858601	CARDENE 20 MG in 200 ML Injection	PSN	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858605	CARDENE 40 MG in 200 ML Injection	PSN	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858599	niCARdipine HCl 20 MG in 200 ML Injection	PSN	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858603	niCARdipine HCl 40 MG in 200 ML Injection	PSN	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858601	200 ML nicardipine hydrochloride 0.1 MG/ML Injection [Cardene]	SBD	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858605	200 ML nicardipine hydrochloride 0.2 MG/ML Injection [Cardene]	SBD	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858599	200 ML nicardipine hydrochloride 0.1 MG/ML Injection	SCD	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858603	200 ML nicardipine hydrochloride 0.2 MG/ML Injection	SCD	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858601	Cardene 20 MG per 200 ML Injection	SY	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858605	Cardene 40 MG per 200 ML Injection	SY	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858599	nicardipine hydrochloride 20 MG per 200 ML Injection	SY	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18
858603	nicardipine hydrochloride 40 MG per 200 ML Injection	SY	f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43066-016-10	43066001610	10 BAG in 1 CARTON (43066-016-10) / 200 mL in 1 BAG	10 bag	2020-10-26	0000-00-00	No	No	Current