Cardene IV

Product NDC
10122-313
11-digit product format
101220313
Labeler code
10122
Product ID
10122-313_35a66ebb-329c-49ad-a047-9c0bf15e8028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Chiesi USA, Inc.
Application
NDA019734
Marketing category
NDA
Marketing start
1992-01-30
Marketing end
2022-06-30
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
0 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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10122-313-101012203131010 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG10 carton1992-01-302022-06-30NoNoCurrent