nicardipine hydrochloride

Product NDC
47335-882
11-digit product format
473350882
Labeler code
47335
Product ID
47335-882_eb896621-8069-4bef-b975-7637eb1e48d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA078405
Marketing category
NDA
Marketing start
2021-05-26
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-882-40ML - Milliliter47335-8823a87dd7f-b271-4a82-809e-68c67d73916e12021-07-15
47335-882-44ML - Milliliter47335-882038f3c2c-b565-4bed-9cc8-9818514a7da212021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-882-444733508824410 CARTON in 1 CARTON (47335-882-44) > 1 AMPULE in 1 CARTON (47335-882-40) > 10 mL in 1 AMPULE10 carton2021-05-260000-00-00NoNoCurrent