FDA.reportPublic FDA data

Pantoprazole sodium

Product NDC
68083-493
11-digit product format
680830493
Labeler code
68083
Product ID
68083-493_6cd73b63-72e7-4f03-955d-fa897f905c2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA204400
Marketing category
ANDA
Marketing start
2022-05-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui283669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-493-01Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
68083-493-01Pantoprazole sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1010
68083-493-10Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
68083-493-10Pantoprazole sodium10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1010
68083-493-25Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
68083-493-25Pantoprazole sodium25 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-493PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]9Current NDC, Legacy NDC, 6 package rows20250223_c1ad8f91-3783-4139-8154-e461a53809c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNc1ad8f91-3783-4139-8154-e461a53809c110
283669pantoprazole 40 MG InjectionSCDc1ad8f91-3783-4139-8154-e461a53809c110
283669pantoprazole (as sodium) 40 MG InjectionSYc1ad8f91-3783-4139-8154-e461a53809c110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-493-01680830493011 VIAL in 1 CARTON (68083-493-01) / 10 mL in 1 VIAL1 vial2022-05-180000-00-00NoNoCurrent
68083-493-106808304931010 CARTON in 1 PACKAGE (68083-493-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL10 carton2022-05-180000-00-00NoNoCurrent
68083-493-256808304932525 CARTON in 1 PACKAGE (68083-493-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL25 carton2022-05-180000-00-00NoNoCurrent