Nicardipine Hydrochloride

Product NDC: 0143-9634
11-digit product format: 001439634
Labeler code: 0143
Product ID: 0143-9634_299a0b28-ebf0-4753-983d-b9a16158d83c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nicardipine Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA022276
Marketing category: NDA
Marketing start: 2016-04-07
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: .1 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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022276-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24
N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07
N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022276-001	AP
N022276-002	AP
N022276-003	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 4 · 126 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	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2016-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022276-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022276-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022276-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022276-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022276-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022276-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022276-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022276-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022276-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022276-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022276-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022276-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022276-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022276-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022276-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022276-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022276-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022276-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022276-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022276-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022276-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022276-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022276-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022276-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022276-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022276-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022276-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022276-001	AP	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicardipine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICARDIPINE HYDROCHLORIDE	.1 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858599	Internal RxNorm lookup
858603	Internal RxNorm lookup
858607	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
18fb1c2b-0c1e-436c-a5b6-d4840b5da228	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9634-01	Nicardipine Hydrochloride	200 mL in 1 BAG	INJECTION	200		13
0143-9634-10	Nicardipine Hydrochloride	10 in 1 CARTON	INJECTION	10		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9634-01	ML - Milliliter	0143-9634	3b75351e-4176-4882-843f-62381350ccb1	1	2020-05-08
0143-9634-10	ML - Milliliter	0143-9634	a2ea7166-20a6-4e6c-badd-2566fc8639fd	1	2020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICARDIPINE HYDROCHLORIDE	ACTIVE INGREDIENT	K5BC5011K3	NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	6
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	6
2,4-DIHYDROXYBENZOIC ACID	INACTIVE INGREDIENT	LU39SC9JYL	NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9634	NICARDIPINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	13	Current NDC, Legacy NDC, 2 package rows	20250327_18fb1c2b-0c1e-436c-a5b6-d4840b5da228.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9d898911-d811-2a78-e053-2995a90af784	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022276 application number: NDA022276
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	2024-08-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022276 application number: NDA022276 ndc (product): 0143-9634
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	55bd6dcc-1f12-4378-8e9e-1ceed26818f5	2021-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022276 application number: NDA022276
Nicardipine Hydrochloride	NICARDIPINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp	0eb7d839-63d9-4b51-bf7b-4a8fde6339b5	2018-12-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022276 application number: NDA022276

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	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858607	niCARdipine HCl 25 MG in 10 ML Injection	PSN	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858603	niCARdipine HCl 40 MG in 200 ML Injection	PSN	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858607	10 ML nicardipine hydrochloride 2.5 MG/ML Injection	SCD	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858599	200 ML nicardipine hydrochloride 0.1 MG/ML Injection	SCD	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858603	200 ML nicardipine hydrochloride 0.2 MG/ML Injection	SCD	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858599	nicardipine hydrochloride 20 MG per 200 ML Injection	SY	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858607	nicardipine hydrochloride 25 MG per 10 ML Injection	SY	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13
858603	nicardipine hydrochloride 40 MG per 200 ML Injection	SY	18fb1c2b-0c1e-436c-a5b6-d4840b5da228	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9634-01	00143963401	200 mL in 1 BAG	200 ml					Historical
0143-9634-10	00143963410	10 BAG in 1 CARTON (0143-9634-10) / 200 mL in 1 BAG (0143-9634-01)	10 bag	2016-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicardipine Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-08-24	HUMAN PRESCRIPTION DRUG LABEL	13