FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
71288-600
11-digit product format
712880600
Labeler code
71288
Product ID
71288-600_48bbc577-3242-4da3-bca3-7a5f89105415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA215860
Marketing category
ANDA
Marketing start
2022-08-29
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
71288-600-10Pantoprazole Sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION106
71288-600-11Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
71288-600-91Pantoprazole Sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION101
71288-600-92Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-600-10EA - Each71288-60051d04097-e4b5-4699-baf2-a6e6be97ecac12023-04-07
71288-600-11EA - Each71288-6007d126adc-cb4c-4b7d-8814-1d270690ff3e12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-600PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20250514_c18aff31-f91e-4b6a-9713-52c9094c6082.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNc18aff31-f91e-4b6a-9713-52c9094c60826
283669pantoprazole 40 MG InjectionSCDc18aff31-f91e-4b6a-9713-52c9094c60826
283669pantoprazole (as sodium) 40 MG InjectionSYc18aff31-f91e-4b6a-9713-52c9094c60826
283669pantoprazole 40 MG InjectionPSN014f9762-6948-46b7-8659-5c89f35ad8bf1
283669pantoprazole 40 MG InjectionSCD014f9762-6948-46b7-8659-5c89f35ad8bf1
283669pantoprazole (as sodium) 40 MG InjectionSY014f9762-6948-46b7-8659-5c89f35ad8bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-600-107128806001010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-600-117128806001110 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-10) 2022-08-290000-00-00NoNoCurrent
71288-600-917128806009110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-600-927128806009210 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-92) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-91) 2022-08-29NoNoCurrent