FDA.reportPublic FDA data

Nicardipine hydrochloride

Product NDC
69238-2691
11-digit product format
692382691
Labeler code
69238
Product ID
69238-2691_8f57d96f-7e5b-409f-9e21-c3ed67369716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218202
Marketing category
ANDA
Marketing start
2024-10-03
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
69238-2691-1Nicardipine hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2691-1EA - Each69238-269196d9d000-bd8d-49d0-b7d6-f90da84ca62712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2691NICARDIPINE HYDROCHLORIDE (NICARDIPINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]1Current NDC, 1 package rows20241004_79304b0f-53d3-4065-8c81-7031d1141694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN79304b0f-53d3-4065-8c81-7031d11416941
858616niCARdipine HCl 30 MG Oral CapsulePSN79304b0f-53d3-4065-8c81-7031d11416941
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD79304b0f-53d3-4065-8c81-7031d11416941
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD79304b0f-53d3-4065-8c81-7031d11416941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2691-16923826910190 CAPSULE in 1 BOTTLE (69238-2691-1) 90 capsule2024-10-03NoNoCurrent