FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
65219-385
11-digit product format
652190385
Labeler code
65219
Product ID
65219-385_452b14d4-4fbd-47b1-b4b1-f0b302e8f0d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA216021
Marketing category
ANDA
Marketing start
2024-08-01
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
65219-385-01Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101
65219-385-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-385-01EA - Each65219-3858fdbbe9f-4c55-452d-aa3d-fc51ee3f4ef712025-07-08
65219-385-10EA - Each65219-385d8dc8dac-f85e-4509-ba04-9eca32da047012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-385PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20250131_340b57c2-bcf8-4f46-b522-886daaf80351.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN340b57c2-bcf8-4f46-b522-886daaf803511
283669pantoprazole 40 MG InjectionSCD340b57c2-bcf8-4f46-b522-886daaf803511
283669pantoprazole (as sodium) 40 MG InjectionSY340b57c2-bcf8-4f46-b522-886daaf803511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-385-016521903850110 mL in 1 VIAL10 mlHistorical
65219-385-106521903851010 VIAL in 1 CARTON (65219-385-10) / 10 mL in 1 VIAL (65219-385-01) 10 vial2025-01-31NoNoCurrent