Nicardipine Hydrochloride

Product NDC
0781-3204
11-digit product format
007813204
Labeler code
0781
Product ID
0781-3204_547aacb1-dd90-4934-80ff-6b3db422175a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
ANDA090125
Marketing category
ANDA
Marketing start
2009-11-17
Marketing end
0000-00-00
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3204-952019-10-29C16284748780-1960f7f55-d2a1-8e05-e053-dbdaa90a074aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3204-70Nicardipine Hydrochloride1 in 1 CARTONINJECTION14
0781-3204-70Nicardipine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION104
0781-3204-95Nicardipine Hydrochloride10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3204-70ML - Milliliter0781-3204170f4f14-4c8a-41e4-a50a-431b9501626912012-07-24
0781-3204-95ML - Milliliter0781-3204692d5bab-9e9b-4cdf-9718-f515f2c841de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4
SORBITOLINACTIVE INGREDIENT506T60A25RNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4
WATERINACTIVE INGREDIENT059QF0KO0RNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3204NICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]4Legacy NDC, 3 package rows20110713_c84cda13-e2fb-46d6-a9a2-5a3311387ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNc84cda13-e2fb-46d6-a9a2-5a3311387ff84
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDc84cda13-e2fb-46d6-a9a2-5a3311387ff84
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYc84cda13-e2fb-46d6-a9a2-5a3311387ff84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0781-3204-70007813204701 in 1 CARTONHistorical
0781-3204-950078132049510 in 1 CARTONHistorical