FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
72572-470
11-digit product format
725720470
Labeler code
72572
Product ID
72572-470_fba70df6-5d37-4a12-bce3-e6fb1b0c72b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA090534
Marketing category
ANDA
Marketing start
2020-10-29
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-470-01Nicardipine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION104
72572-470-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-470NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20201029_30fb3a4d-fa75-42fd-b4b6-2a21f202027f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN30fb3a4d-fa75-42fd-b4b6-2a21f202027f4
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD30fb3a4d-fa75-42fd-b4b6-2a21f202027f4
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY30fb3a4d-fa75-42fd-b4b6-2a21f202027f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-470-017257204700110 mL in 1 VIAL10 mlHistorical
72572-470-107257204701010 VIAL in 1 CARTON (72572-470-10) / 10 mL in 1 VIAL (72572-470-01) 10 vial2020-10-290000-00-00NoNoCurrent