NICARDIPINE HYDROCHLORIDE

Product NDC: 87564-027
11-digit product format: 875640027
Labeler code: 87564
Product ID: 87564-027_575c5db5-2aed-1948-e063-6294a90a34a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicardipine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Amerisyn LLC
Application: ANDA215377
Marketing category: ANDA
Marketing start: 2026-07-26
Substance: NICARDIPINE HYDROCHLORIDE
Active strength: 20 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215377-001	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB		2023-07-17
A215377-002	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB		2023-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215377-001	AB
A215377-002	AB

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 · 44 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
2026-09-14 22:38:34	2026-08	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-001	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE / ORAL	AB	2023-07-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-002	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-07-17	`a72a2bbeb626…`

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
2026-09-14 22:38:34	2026-08	A215377-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215377-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215377-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215377-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215377-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215377-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215377-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215377-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215377-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215377-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215377-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215377-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215377-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215377-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215377-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215377-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215377-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215377-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215377-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215377-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215377-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215377-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-002	AB	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-001	CGT	2024-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215377-002	CGT	2024-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-001	CGT	2024-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215377-002	CGT	2024-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-001	CGT	2024-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215377-002	CGT	2024-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-001	CGT	2024-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215377-002	CGT	2024-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215377-001	CGT	2024-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215377-002	CGT	2024-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-001	CGT	2024-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215377-002	CGT	2024-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-001	CGT	2024-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215377-002	CGT	2024-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-001	CGT	2024-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215377-002	CGT	2024-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215377-001	CGT	2024-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215377-002	CGT	2024-03-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-001	CGT	2024-03-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215377-002	CGT	2024-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215377-001	CGT	2024-03-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215377-002	CGT	2024-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215377-001	CGT	2024-03-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215377-002	CGT	2024-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-001	CGT	2024-03-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215377-002	CGT	2024-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215377-001	CGT	2024-03-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215377-002	CGT	2024-03-20	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: NICARDIPINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICARDIPINE HYDROCHLORIDE	20 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858613	Internal RxNorm lookup
858616	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
575c5dab-e832-192a-e063-6294a90a34a1	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Amerisyn LLC	575c5dab-e832-192a-e063-6294a90a34a1	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215377 application number: ANDA215377 ndc (product): 87564-027
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Amici Pharma Inc	edda985c-004e-4487-b856-13cf2cdb900f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215377 application number: ANDA215377
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	Burel Pharmaceuticals, LLC	cb902af0-b5ad-4680-b2f2-007ef2196efe	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215377 application number: ANDA215377

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	Sample	Exclude flag	Status
87564-027-90	87564002790	90 CAPSULE in 1 BOTTLE (87564-027-90)	90 capsule	2026-07-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicardipine Hydrochloride Capsules Rx Only	Amerisyn LLC	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1