nicardipine hydrochloride

Product NDC: 47335-882
11-digit product format: 473350882
Labeler code: 47335
Product ID: 47335-882_eb896621-8069-4bef-b975-7637eb1e48d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicardipine hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA078405
Marketing category: NDA
Marketing start: 2021-05-26
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: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	47335-882		D	Discontinued by firm		2026-08-03
excluded package	package	47335-882	47335-882-44	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 12 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47335-882	47335-882-44	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47335-882	47335-882-44	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47335-882	47335-882-44	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47335-882	47335-882-44	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47335-882	47335-882-44	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	47335-882		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47335-882	47335-882-44	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N078405-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION			2009-11-17

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N078405-001	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	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION		2009-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N078405-001	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE / INJECTION	AP	2009-11-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N078405-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N078405-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N078405-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N078405-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N078405-001	AP	1	`782e0a99824c…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N078405-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N078405-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N078405-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N078405-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N078405-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N078405-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N078405-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N078405-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-882-40	ML - Milliliter	47335-882	3a87dd7f-b271-4a82-809e-68c67d73916e	1	2021-07-15
47335-882-44	ML - Milliliter	47335-882	038f3c2c-b565-4bed-9cc8-9818514a7da2	1	2021-07-15

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K5BC5011K3	NICARDIPINE HYDROCHLORIDE	54527-84-3	NICARDIPINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-882-44	47335088244	10 CARTON in 1 CARTON (47335-882-44) > 1 AMPULE in 1 CARTON (47335-882-40) > 10 mL in 1 AMPULE	10 carton	2021-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
nicardipine hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2021-04-23	Human Prescription Drug Label	4