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

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
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
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

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