PANTOPRAZOLE SODIUM

Product NDC
62756-129
11-digit product format
627560129
Labeler code
62756
Product ID
62756-129_ef1bb9ed-b534-4698-abf5-836dcce85f45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077674
Marketing category
ANDA
Marketing start
2019-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PANTOPRAZOLE SODIUM
Listing expiration
2026-12-31

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
62756-129-40PANTOPRAZOLE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18
62756-129-40PANTOPRAZOLE SODIUM10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
62756-129-44PANTOPRAZOLE SODIUM10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108
62756-129-44PANTOPRAZOLE SODIUM10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
62756-129-45PANTOPRAZOLE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18
62756-129-45PANTOPRAZOLE SODIUM25 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-129PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 6 package rows20250216_d9fcf6a2-3788-4955-84d9-3c319b13267c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNd9fcf6a2-3788-4955-84d9-3c319b13267c8
283669pantoprazole 40 MG InjectionSCDd9fcf6a2-3788-4955-84d9-3c319b13267c8
283669pantoprazole (as sodium) 40 MG InjectionSYd9fcf6a2-3788-4955-84d9-3c319b13267c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-129-40627560129401 VIAL in 1 CARTON (62756-129-40) / 10 mL in 1 VIAL1 vial2019-09-010000-00-00NoNoCurrent
62756-129-446275601294410 VIAL in 1 CARTON (62756-129-44) / 10 mL in 1 VIAL10 vial2019-09-010000-00-00NoNoCurrent
62756-129-456275601294525 CARTON in 1 PACKAGE (62756-129-45) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL25 carton2019-09-010000-00-00NoNoCurrent