NICARDIPINE HYDROCHLORIDE

Product NDC
51662-1482
11-digit product format
516621482
Labeler code
51662
Product ID
51662-1482_2b39b839-0c80-de03-e063-6294a90a243e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NICARDIPINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA022276
Marketing category
NDA
Marketing start
2020-02-01
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
25 mg/10mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022276-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24
N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07
N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N022276-001AP
N022276-002AP
N022276-003AP

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022276-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N022276-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022276-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022276-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022276-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022276-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022276-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022276-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022276-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022276-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022276-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022276-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022276-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022276-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022276-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022276-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022276-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022276-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022276-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022276-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022276-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022276-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022276-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022276-001AP19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
NICARDIPINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE25 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K5BC5011K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858607Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d898911-d811-2a78-e053-2995a90af784Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1482-1NICARDIPINE HYDROCHLORIDE10 mL in 1 VIALINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1482NICARDIPINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20250110_9d898911-d811-2a78-e053-2995a90af784.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9d898911-d811-2a78-e053-2995a90af7842025-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
ndc (product): 51662-1482
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.18fb1c2b-0c1e-436c-a5b6-d4840b5da2282024-08-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.55bd6dcc-1f12-4378-8e9e-1ceed26818f52021-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp0eb7d839-63d9-4b51-bf7b-4a8fde6339b52018-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN9d898911-d811-2a78-e053-2995a90af7843
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD9d898911-d811-2a78-e053-2995a90af7843
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY9d898911-d811-2a78-e053-2995a90af7843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1482-15166214820110 mL in 1 VIAL (51662-1482-1) 10 ml2020-02-010000-00-00NoNoCurrent