FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
0143-9689
11-digit product format
001439689
Labeler code
0143
Product ID
0143-9689_299a0b28-ebf0-4753-983d-b9a16158d83c
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
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

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 Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858599, 858603, 858607

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9689-01Nicardipine Hydrochloride10 mL in 1 VIALINJECTION1013
0143-9689-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9689-01ML - Milliliter0143-96890640c282-f835-4493-8941-e3f63a459f2e12018-03-08
0143-9689-10ML - Milliliter0143-9689baf4c71a-15b3-4c31-9ad5-7d6d8c46f38012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]6
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]6
2,4-DIHYDROXYBENZOIC ACIDINACTIVE INGREDIENTLU39SC9JYLNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9689NICARDIPINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20250327_18fb1c2b-0c1e-436c-a5b6-d4840b5da228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSN18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858603niCARdipine HCl 40 MG in 200 ML InjectionPSN18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCD18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCD18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSY18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSY18fb1c2b-0c1e-436c-a5b6-d4840b5da22813
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
0143-9689-010014396890110 mL in 1 VIAL10 mlHistorical
0143-9689-100014396891010 VIAL in 1 CARTON (0143-9689-10) / 10 mL in 1 VIAL (0143-9689-01) 10 vial2012-03-020000-00-00NoNoCurrent