CARDENE IV

Product NDC: 43066-029
Requested package NDC: 43066-029-10
11-digit product format: 430660029
Labeler code: 43066
Product ID: 43066-029_5749599d-ff2a-42e4-aa72-cd25013feee8
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: 2.5 mg/10mL
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NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1992-01-30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…`

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	2.5 mg/10mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858607	Internal RxNorm lookup
858609	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
5749599d-ff2a-42e4-aa72-cd25013feee8	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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43066-029-01	CARDENE IV	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		1
43066-029-10	CARDENE IV	10 in 1 CARTON	INJECTION, SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43066-029-01	ML - Milliliter	43066-029	10b87bd8-bbaa-48e1-82e3-667fe22df347	1	2026-04-20
43066-029-10	ML - Milliliter	43066-029	6b41d85a-8f8a-4cb3-9ae5-ffda7178fb4f	1	2026-04-20

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
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
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 (package): 43066-029-10 ndc (product): 43066-029 ndc11 (package): 43066002910

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
858609	CARDENE 25 MG in 10 ML Injection	PSN	5749599d-ff2a-42e4-aa72-cd25013feee8	1
858607	niCARdipine HCl 25 MG in 10 ML Injection	PSN	5749599d-ff2a-42e4-aa72-cd25013feee8	1
858609	10 ML nicardipine hydrochloride 2.5 MG/ML Injection [Cardene]	SBD	5749599d-ff2a-42e4-aa72-cd25013feee8	1
858607	10 ML nicardipine hydrochloride 2.5 MG/ML Injection	SCD	5749599d-ff2a-42e4-aa72-cd25013feee8	1
858609	Cardene 25 MG per 10 ML Injection	SY	5749599d-ff2a-42e4-aa72-cd25013feee8	1
858607	nicardipine hydrochloride 25 MG per 10 ML Injection	SY	5749599d-ff2a-42e4-aa72-cd25013feee8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
43066-029-10	43066002910	10 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10) / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01)	2025-12-29	No	No	Current