Nicardipine Hydrochloride

Product NDC
70710-2011
11-digit product format
707102011
Labeler code
70710
Product ID
70710-2011_bf108728-380c-41b5-a730-1ddd2c0051ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA218638
Marketing category
ANDA
Marketing start
2025-08-01
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 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
70710-2011-9Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN861247cc-3edf-4497-b230-2147489548b31
858616niCARdipine HCl 30 MG Oral CapsulePSN861247cc-3edf-4497-b230-2147489548b31
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD861247cc-3edf-4497-b230-2147489548b31
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD861247cc-3edf-4497-b230-2147489548b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-2011-97071020110990 CAPSULE in 1 BOTTLE (70710-2011-9) 90 capsule2025-08-01NoNoCurrent