PANTOPRAZOLE SODIUM

Product NDC
0781-3480
11-digit product format
007813480
Labeler code
0781
Product ID
0781-3480_38e9f0e0-9691-4c5d-b4aa-d3d314df242c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA209524
Marketing category
ANDA
Marketing start
2026-01-26
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
Brand name suffix
I.V.
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
0781-3480-95PANTOPRAZOLE SODIUMI.V.10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
0781-3480-95PANTOPRAZOLE SODIUMI.V.10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3480-95EA - Each0781-3480124c23b1-d7b5-4321-ad03-0bcffb2f792212026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN22b71a1d-87f8-43ba-b53d-53ca3f70c63e2
283669pantoprazole 40 MG InjectionSCD22b71a1d-87f8-43ba-b53d-53ca3f70c63e2
283669pantoprazole (as sodium) 40 MG InjectionSY22b71a1d-87f8-43ba-b53d-53ca3f70c63e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3480-950078134809510 VIAL in 1 CARTON (0781-3480-95) / 10 mL in 1 VIAL10 vial2026-01-26NoNoHistorical