Nicardipine Hydrochloride

Product NDC
64679-631
11-digit product format
646790631
Labeler code
64679
Product ID
64679-631_3f6bbe56-5d77-499b-ba75-9129b87a1592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA090671
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-631-01ML - Milliliter64679-631d3d1a2a4-4049-4e6d-8110-62bab493d76312012-07-24
64679-631-02ML - Milliliter64679-631e9a672b4-c95a-40fe-a133-2db7464c948a12012-07-24
64679-631-03ML - Milliliter64679-6312c0c6771-2eb9-40b7-a7fe-a1d75deb419912024-10-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-631NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT USA LLC.]7Legacy NDC20240907_e61159ba-ff6b-4696-a642-4f64c79c4708.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-631-01646790631011 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-01) > 10 mL in 1 VIAL, SINGLE-DOSE (64679-631-03) 2009-11-170000-00-00NoNoCurrent
64679-631-026467906310210 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-02) > 10 mL in 1 VIAL, SINGLE-DOSE (64679-631-03) 2009-11-170000-00-00NoNoCurrent