Nicardipine Hydrochloride

Product NDC: 40042-047
11-digit product format: 400420047
Labeler code: 40042
Product ID: 40042-047_48a0e4e8-5520-4789-b508-deef6d0f3aa1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nicardipine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: PharmaForce, Inc.
Application: ANDA090534
Marketing category: ANDA
Marketing start: 2009-11-17
Marketing end: 0000-00-00
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: 3 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: E
Listing certified through: 2017-12-31
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	40042-047		I	Inactivated by FDA		2026-08-17
excluded package	package	40042-047	40042-047-10	I	Inactivated by FDA		2026-08-17

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 · 44 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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`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	40042-047-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40042-047-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40042-047-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40042-047-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	40042-047-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	40042-047-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	40042-047-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	40042-047-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	40042-047-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	40042-047-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	40042-047-10	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

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

Therapeutic equivalence codes#

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

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		RS	2009-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090534-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-11-17	`e64feba35796…`

Observed Orange Book normalized TE history#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40042-047-10	2019-10-21	C162847	48780-1	956f9ecf-c000-621f-e053-dbdaa90a74ad	Nicardipine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40042-047-10	Nicardipine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		1
40042-047-10	Nicardipine Hydrochloride	10 mL in 1 VIAL	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
40042-047-10	ML - Milliliter	40042-047	147e9185-c65f-4b56-9fb8-d06dc0f5cb95	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICARDIPINE HYDROCHLORIDE	ACTIVE INGREDIENT	K5BC5011K3	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40042-047	NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]	1	Legacy NDC, 2 package rows	20091119_be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

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

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
858607	niCARdipine HCl 25 MG in 10 ML Injection	PSN	be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee	1
858607	10 ML nicardipine hydrochloride 2.5 MG/ML Injection	SCD	be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee	1
858607	nicardipine hydrochloride 25 MG per 10 ML Injection	SY	be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
40042-047-10	40042004710	10 in 1 CARTON	Historical