FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
0143-9542
11-digit product format
001439542
Labeler code
0143
Product ID
0143-9542_b87038d9-8a91-428b-8d7f-6eef3a836742
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA022276
Marketing category
NDA
Marketing start
2012-03-02
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
2.5 mg/mL
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022276-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAPRLD, RS2008-07-24a50c72e98297…
2026-08-01 22:54:322026-06N022276-002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/200ML (0.1MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07a50c72e98297…
2026-08-01 22:54:322026-06N022276-003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE40MG/200ML (0.2MG/ML)INJECTABLE / INTRAVENOUSAPRLD, RS2016-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022276-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N022276-002AP1a50c72e98297…
2026-08-01 22:54:322026-06N022276-003AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
ndc (product): 0143-9542
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp0eb7d839-63d9-4b51-bf7b-4a8fde6339b52018-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 022276
application number: NDA022276

Additional Listing Data#

Finished product
Yes
Brand name base
Nicardipine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE2.5 mg/mL

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
55bd6dcc-1f12-4378-8e9e-1ceed26818f5Available 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
0143-9542-01Nicardipine Hydrochloride10 mL in 1 VIALINJECTION106
0143-9542-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9542-01ML - Milliliter0143-9542a45afe5c-6adb-48f7-9b1a-c759167d455712015-08-04
0143-9542-10ML - Milliliter0143-9542f791ccae-904e-46a3-88b8-38c10ca14a2d12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]2
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]2
2,4-DIHYDROXYBENZOIC ACIDINACTIVE INGREDIENTLU39SC9JYLNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9542NICARDIPINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20220427_55bd6dcc-1f12-4378-8e9e-1ceed26818f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN55bd6dcc-1f12-4378-8e9e-1ceed26818f56
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD55bd6dcc-1f12-4378-8e9e-1ceed26818f56
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY55bd6dcc-1f12-4378-8e9e-1ceed26818f56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9542-010014395420110 mL in 1 VIAL10 mlHistorical
0143-9542-100014395421010 VIAL in 1 CARTON (0143-9542-10) / 10 mL in 1 VIAL (0143-9542-01) 10 vial2012-03-020000-00-00NoNoCurrent