CARDENE IV

Product NDC
43066-029
11-digit product format
430660029
Labeler code
43066
Product ID
43066-029_5749599d-ff2a-42e4-aa72-cd25013feee8
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
2.5 mg/10mL
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 HYDROCHLORIDE2.5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858607, 858609

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-029-01CARDENE IV10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
43066-029-10CARDENE IV10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-029-01ML - Milliliter43066-02910b87bd8-bbaa-48e1-82e3-667fe22df34712026-04-20
43066-029-10ML - Milliliter43066-0296b41d85a-8f8a-4cb3-9ae5-ffda7178fb4f12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858609CARDENE 25 MG in 10 ML InjectionPSN5749599d-ff2a-42e4-aa72-cd25013feee81
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN5749599d-ff2a-42e4-aa72-cd25013feee81
85860910 ML nicardipine hydrochloride 2.5 MG/ML Injection [Cardene]SBD5749599d-ff2a-42e4-aa72-cd25013feee81
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD5749599d-ff2a-42e4-aa72-cd25013feee81
858609Cardene 25 MG per 10 ML InjectionSY5749599d-ff2a-42e4-aa72-cd25013feee81
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY5749599d-ff2a-42e4-aa72-cd25013feee81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-029-014306600290110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
43066-029-104306600291010 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10) / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01) 2025-12-29NoNoHistorical