Nicardipine Hydrochloride

Product NDC
55648-631
11-digit product format
556480631
Labeler code
55648
Product ID
55648-631_1aa072e3-8f11-4e34-8d13-bc0021f33713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Wockhardt Limited
Application
ANDA090671
Marketing category
ANDA
Marketing start
2009-11-09
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
No
Listing certified through
2019-12-31
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
55648-631-022020-01-31C16284748780-19d75b9d1-1716-f424-e053-dadaa90a57ceNicardipine Hydrochloride Injection Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-631-01Nicardipine Hydrochloride1 in 1 CARTONINJECTION13
55648-631-01Nicardipine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION103
55648-631-02Nicardipine Hydrochloride10 in 1 CARTONINJECTION103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
SORBITOLINACTIVE INGREDIENT506T60A25RNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
WATERINACTIVE INGREDIENT059QF0KO0RNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-631NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3Legacy NDC, 3 package rows20121012_a6512740-17e0-4f22-a233-4ac084277879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNa6512740-17e0-4f22-a233-4ac0842778793
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDa6512740-17e0-4f22-a233-4ac0842778793
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYa6512740-17e0-4f22-a233-4ac0842778793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-631-01556480631011 in 1 CARTONHistorical
55648-631-025564806310210 in 1 CARTONHistorical