FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
25021-751
11-digit product format
250210751
Labeler code
25021
Product ID
25021-751_2b04a735-571c-4668-bc78-ac3a611d575c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA204400
Marketing category
ANDA
Marketing start
2022-07-15
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
25021-751-10Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,109
25021-751-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,109
25021-751-11Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,109
25021-751-11Pantoprazole Sodium25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-751-10EA - Each25021-751987ac39d-5641-4a25-be25-9a83e81858d412022-09-12
25021-751-11EA - Each25021-751bd5fbee6-8a24-49e4-a7af-29f0cc68324412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-751PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20241215_c39be14b-e881-4586-b77e-4747db494954.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNc39be14b-e881-4586-b77e-4747db4949549
283669pantoprazole 40 MG InjectionSCDc39be14b-e881-4586-b77e-4747db4949549
283669pantoprazole (as sodium) 40 MG InjectionSYc39be14b-e881-4586-b77e-4747db4949549

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-751-102502107511010 VIAL in 1 CARTON (25021-751-10) / 10 mL in 1 VIAL10 vial2022-07-150000-00-00NoNoCurrent
25021-751-112502107511125 VIAL in 1 CARTON (25021-751-11) / 10 mL in 1 VIAL25 vial2022-07-150000-00-00NoNoCurrent