FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
55150-202
11-digit product format
551500202
Labeler code
55150
Product ID
55150-202_7de2a288-9f73-44ec-a42d-ea76d1018645
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205675
Marketing category
ANDA
Marketing start
2016-03-30
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/1
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/1

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
55150-202-00Pantoprazole Sodium1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION116
55150-202-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
55150-202-25Pantoprazole Sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-202-00EA - Each55150-20229f813db-3ff4-4a2a-9360-88981763e43d12016-05-16
55150-202-10EA - Each55150-2021df55ba4-2039-4282-9a9c-03e316d1cec212016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-202PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]16Current NDC, Legacy NDC, 3 package rows20250322_9bed093a-9586-4c82-a2b7-c68f89d0faef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN9bed093a-9586-4c82-a2b7-c68f89d0faef16
283669pantoprazole 40 MG InjectionSCD9bed093a-9586-4c82-a2b7-c68f89d0faef16
283669pantoprazole (as sodium) 40 MG InjectionSY9bed093a-9586-4c82-a2b7-c68f89d0faef16
283669pantoprazole 40 MG InjectionPSN4ba4c797-3f97-4d85-971e-7b17bdf892217
283669pantoprazole 40 MG InjectionSCD4ba4c797-3f97-4d85-971e-7b17bdf892217
283669pantoprazole (as sodium) 40 MG InjectionSY4ba4c797-3f97-4d85-971e-7b17bdf892217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-202-00551500202001 in 1 VIAL, SINGLE-DOSEHistorical
55150-202-105515002021010 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00) 2016-03-300000-00-00NoNoCurrent
55150-202-255515002022525 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00) 2016-03-300000-00-00NoNoCurrent