FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
24658-750
11-digit product format
246580750
Labeler code
24658
Product ID
24658-750_69c60be8-143d-4a50-8a66-46c01c416372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application
ANDA074928
Marketing category
ANDA
Marketing start
2016-12-15
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
20 mg/1
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858613, 858616

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
24658-750-90Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-750-90EA - Each24658-750a86acd54-617d-4d71-8151-33bf436e67e312017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-750NICARDIPINE HYDROCHLORIDE CAPSULE [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]5Current NDC, Legacy NDC, 1 package rows20190108_065efabf-8c7d-4dd5-aef2-700c2eca399d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN065efabf-8c7d-4dd5-aef2-700c2eca399d5
858616niCARdipine HCl 30 MG Oral CapsulePSN065efabf-8c7d-4dd5-aef2-700c2eca399d5
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD065efabf-8c7d-4dd5-aef2-700c2eca399d5
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD065efabf-8c7d-4dd5-aef2-700c2eca399d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24658-750-902465807509090 CAPSULE in 1 BOTTLE (24658-750-90) 90 capsule2016-12-150000-00-00NoNoCurrent