Pantoprazole Sodium

Product NDC
65219-433
11-digit product format
652190433
Labeler code
65219
Product ID
65219-433_c8271ff9-84e1-4e27-9646-130715be4bd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090296
Marketing category
ANDA
Marketing start
2021-08-27
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/10mL
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump 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
65219-433-01EA - Each65219-4339bc30363-cd7e-4d34-b671-67107f15dd2b12021-09-07
65219-433-15EA - Each65219-43357da06cf-583e-4bcc-b615-49cd1730ed2212021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-433PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Legacy NDC20250228_c8271ff9-84e1-4e27-9646-130715be4bd4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-433-156521904331510 VIAL in 1 CARTON (65219-433-15) > 10 mL in 1 VIAL (65219-433-01) 10 vial2021-08-270000-00-00NoNoCurrent