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 1.

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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022276-002	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022276-003	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2016-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022276-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2008-07-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022276-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022276-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022276-002	AP	1	`a50c72e98297…`

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
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

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

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