Nicardipine Hydrochloride

Product NDC: 0378-1430
Requested package NDC: 0378-1430-77
11-digit product format: 003781430
Labeler code: 0378
Product ID: 0378-1430_f485be32-7e98-4046-a125-b5453c3c2c74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicardipine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074642
Marketing category: ANDA
Marketing start: 1996-07-19
Marketing end: 2030-01-31
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: 30 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-1430	0378-1430-77	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074642-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18
A074642-002	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18

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 3 · 82 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	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB		1996-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	RS	1996-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074642-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			1996-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074642-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1996-07-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074642-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074642-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074642-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074642-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074642-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074642-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074642-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074642-002	AB	1	`ea99ee380514…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1430-05	EA - Each	0378-1430	17141ffc-6e0d-40eb-8487-10c17e314467	1	2012-07-24
0378-1430-77	EA - Each	0378-1430	17bf838f-ea6e-4ab2-ac22-0c6cbac7a2d3	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 CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NICARDIPINE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
NICARDIPINE HYDROCHLORIDE	ACTIVE INGREDIENT	K5BC5011K3	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
NICARDIPINE	ACTIVE MOIETY	CZ5312222S	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2

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
858616	niCARdipine HCl 30 MG Oral Capsule	PSN	0555647b-1a62-48b8-8821-ef38b996efb7	4
858616	nicardipine hydrochloride 30 MG Oral Capsule	SCD	0555647b-1a62-48b8-8821-ef38b996efb7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1430-77	00378143077	90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-77)	90 capsule	1996-07-19	2030-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicardipine Hydrochloride - Carilion Materials Management	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Nicardipine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2016-09-27	HUMAN PRESCRIPTION DRUG LABEL	8