Nicardipine Hydrochloride

Product NDC
25021-333
11-digit product format
250210333
Labeler code
25021
Product ID
25021-333_b5132d2b-418f-461f-9270-de5c89e2a514
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA219608
Marketing category
ANDA
Marketing start
2026-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicardipine Hydrochloride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-333-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-333-10Nicardipine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-333-10ML - Milliliter25021-33362d94fb4-8e40-45b9-9857-a793a5ca00a812026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNc576c9d5-853b-4e93-be6c-3579dfa5564c1
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDc576c9d5-853b-4e93-be6c-3579dfa5564c1
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYc576c9d5-853b-4e93-be6c-3579dfa5564c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-333-102502103331010 VIAL in 1 CARTON (25021-333-10) / 10 mL in 1 VIAL10 vial2026-01-01NoNoHistorical