PANTOPRAZOLE SODIUM

Product NDC
66794-258
11-digit product format
667940258
Labeler code
66794
Product ID
66794-258_390349ed-4093-e0b3-e063-6294a90a474e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care
Application
ANDA214680
Marketing category
ANDA
Marketing start
2023-10-10
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
Brand name suffix
I.V.
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
66794-258-41PANTOPRAZOLE SODIUMI.V.1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION15
66794-258-41PANTOPRAZOLE SODIUMI.V.10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-258PANTOPRAZOLE SODIUM I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [PIRAMAL CRITICAL CARE]4Current NDC, 2 package rows20240502_0696b10c-972b-9dcf-e063-6294a90a1034.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN0696b10c-972b-9dcf-e063-6294a90a10345
283669pantoprazole 40 MG InjectionSCD0696b10c-972b-9dcf-e063-6294a90a10345
283669pantoprazole (as sodium) 40 MG InjectionSY0696b10c-972b-9dcf-e063-6294a90a10345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66794-258-41667940258411 VIAL in 1 CARTON (66794-258-41) / 10 mL in 1 VIAL1 vial2023-10-10NoNoHistorical