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

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 Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858607

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