FDA.reportPublic FDA data

NICARDIPINE HYDROCHLORIDE

Product NDC
69097-007
11-digit product format
690970007
Labeler code
69097
Product ID
69097-007_d477e259-4e07-433c-b230-d3dd63331866
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA215592
Marketing category
ANDA
Marketing start
2024-10-02
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
.1 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 HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCZ5312222S, K5BC5011K3
Rxcui858599, 858603

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
69097-007-22NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION104
69097-007-45NICARDIPINE HYDROCHLORIDE200 mL in 1 BAGINJECTION2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-007NICARDIPINE HYDROCHLORIDE INJECTION [CIPLA USA INC.]3Current NDC, 2 package rows20241003_570af1f8-6718-4b40-ae89-0f738d330ebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSN570af1f8-6718-4b40-ae89-0f738d330ebd4
858603niCARdipine HCl 40 MG in 200 ML InjectionPSN570af1f8-6718-4b40-ae89-0f738d330ebd4
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCD570af1f8-6718-4b40-ae89-0f738d330ebd4
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCD570af1f8-6718-4b40-ae89-0f738d330ebd4
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSY570af1f8-6718-4b40-ae89-0f738d330ebd4
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSY570af1f8-6718-4b40-ae89-0f738d330ebd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-007-226909700072210 BAG in 1 CARTON (69097-007-22) / 200 mL in 1 BAG (69097-007-45) 10 bag2024-10-02NoNoCurrent
69097-007-4569097000745200 mL in 1 BAG200 mlHistorical