Cardene IV

Product NDC: 10122-314
11-digit product format: 101220314
Labeler code: 10122
Product ID: 10122-314_35a66ebb-329c-49ad-a047-9c0bf15e8028
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicardipine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Chiesi USA, Inc.
Application: NDA019734
Marketing category: NDA
Marketing start: 1992-01-30
Marketing end: 2022-06-30
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: 0 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10122-314		D	Discontinued by firm		2026-09-14
excluded package	package	10122-314	10122-314-10	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10122-314-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10122-314-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10122-314-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10122-314-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10122-314-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10122-314-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10122-314-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10122-314-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10122-314-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10122-314-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10122-314-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10122-314-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 215 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	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-11-07	`84e616aacf4f…`
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…`

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	N019734-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	AP	1	`84e616aacf4f…`
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 · 880 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019734-002	10758616	2027-04-18		Drug product	2020-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	11547758	2027-04-18	U-1029		2023-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	7659291	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	8455524	2027-04-18	U-1029		2013-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	7612102	2027-12-26		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-002	9364564	2027-12-26		Drug product	2016-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	10758616	2027-04-18		Drug product	2020-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	11547758	2027-04-18	U-1029		2023-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	7659291	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	8455524	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	7612102	2027-12-26		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-003	9364564	2027-12-26		Drug product	2016-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	10758616	2027-04-18		Drug product	2020-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	11547758	2027-04-18	U-1029		2023-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	7659291	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	8455524	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	7612102	2027-12-26		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-004	9364564	2027-12-26		Drug product	2016-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-005	7659291	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-005	8455524	2027-04-18	U-1029			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-005	7612102	2027-12-26		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019734-005	9364564	2027-12-26		Drug product	2016-07-08	`84e616aacf4f…`
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…`

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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICARDIPINE HYDROCHLORIDE	ACTIVE INGREDIENT	K5BC5011K3	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [CHIESI USA, INC.]	6

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

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
858599	niCARdipine HCl 20 MG in 200 ML Injection	PSN	a14a6a4d-232b-634f-e053-2a95a90a2323	1
858599	200 ML nicardipine hydrochloride 0.1 MG/ML Injection	SCD	a14a6a4d-232b-634f-e053-2a95a90a2323	1
858599	nicardipine hydrochloride 20 MG per 200 ML Injection	SY	a14a6a4d-232b-634f-e053-2a95a90a2323	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10122-314-10	10122031410	10 CARTON in 1 BOX (10122-314-10) > 1 BAG in 1 CARTON (10122-314-01) > 200 mL in 1 BAG	10 carton	1992-01-30	2022-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NICARDIPINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	2020-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Cardene IV	Chiesi USA, Inc.	2020-02-10	HUMAN PRESCRIPTION DRUG LABEL	12