FDA.reportPublic FDA data

CARDENE IV

Product NDC
43066-009
11-digit product format
430660009
Labeler code
43066
Product ID
43066-009_29b8dd22-cb60-44ee-b715-3f185a1118a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019734
Marketing category
NDA
Marketing start
1992-01-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARDENE IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858599, 858601, 858603, 858605

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
43066-009-10CARDENE IV200 mL in 1 BAGINJECTION, SOLUTION20018
43066-009-10CARDENE IV10 in 1 CARTONINJECTION, SOLUTION1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-009CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16Current NDC, Legacy NDC, 2 package rows20250303_f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858601CARDENE 20 MG in 200 ML InjectionPSNf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858605CARDENE 40 MG in 200 ML InjectionPSNf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858599niCARdipine HCl 20 MG in 200 ML InjectionPSNf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858603niCARdipine HCl 40 MG in 200 ML InjectionPSNf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858601200 ML nicardipine hydrochloride 0.1 MG/ML Injection [Cardene]SBDf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858605200 ML nicardipine hydrochloride 0.2 MG/ML Injection [Cardene]SBDf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCDf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCDf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858601Cardene 20 MG per 200 ML InjectionSYf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858605Cardene 40 MG per 200 ML InjectionSYf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSYf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSYf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43066-009-104306600091010 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG10 bag2021-01-110000-00-00NoNoCurrent