Nicardipine Hydrochloride

Product NDC: 70710-2011
Requested package NDC: 70710-2011-9
11-digit product format: 707102011
Labeler code: 70710
Product ID: 70710-2011_bf108728-380c-41b5-a730-1ddd2c0051ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nicardipine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA218638
Marketing category: ANDA
Marketing start: 2025-08-01
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: 30 mg/1
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

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	70710-2011	70710-2011-9	D	Discontinued by firm		2026-08-17

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

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
A218638-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL			2025-06-25
A218638-002	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2025-06-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL		2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2025-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2025-06-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218638-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL		2025-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218638-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2025-06-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218638-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218638-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218638-002	AB	1	`6a471c1ec25d…`

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-2011-9	Nicardipine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		1

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
858613	niCARdipine HCl 20 MG Oral Capsule	PSN	861247cc-3edf-4497-b230-2147489548b3	1
858616	niCARdipine HCl 30 MG Oral Capsule	PSN	861247cc-3edf-4497-b230-2147489548b3	1
858613	nicardipine hydrochloride 20 MG Oral Capsule	SCD	861247cc-3edf-4497-b230-2147489548b3	1
858616	nicardipine hydrochloride 30 MG Oral Capsule	SCD	861247cc-3edf-4497-b230-2147489548b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70710-2011-9	70710201109	90 CAPSULE in 1 BOTTLE (70710-2011-9)	90 capsule	2025-08-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicardipine Hydrochloride Capsules Rx only	Zydus Pharmaceuticals USA Inc. \| Navinta LLC	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	1