FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
0338-9644
11-digit product format
003389644
Labeler code
0338
Product ID
0338-9644_290e26a2-61f1-4840-9819-205212c7d365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium in 0.9% Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA217512
Marketing category
NDA
Marketing start
2024-02-14
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/100mL
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/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui2675781, 2675784, 2675786

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9644-01PANTOPRAZOLE SODIUM100 mL in 1 BAGINJECTION, SOLUTION1004
0338-9644-12PANTOPRAZOLE SODIUM12 in 1 CARTONINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9644-01ML - Milliliter0338-964427b344f3-899f-48da-b291-0ecd865fb8de12024-12-10
0338-9644-12ML - Milliliter0338-9644f7ca272a-a1f6-4faf-a96d-e9d9c256aa3d12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9644PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, 2 package rows20250109_a476e063-9450-4793-9a22-16b0a0a61cd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675781pantoprazole 40 MG in 100 ML InjectionPSNa476e063-9450-4793-9a22-16b0a0a61cd04
2675784pantoprazole 40 MG in 50 ML InjectionPSNa476e063-9450-4793-9a22-16b0a0a61cd04
2675786pantoprazole 80 MG in 100 ML InjectionPSNa476e063-9450-4793-9a22-16b0a0a61cd04
2675781100 ML pantoprazole 0.4 MG/ML InjectionSCDa476e063-9450-4793-9a22-16b0a0a61cd04
2675786100 ML pantoprazole 0.8 MG/ML InjectionSCDa476e063-9450-4793-9a22-16b0a0a61cd04
267578450 ML pantoprazole 0.8 MG/ML InjectionSCDa476e063-9450-4793-9a22-16b0a0a61cd04
2675781pantoprazole (as sodium) 40 MG per 100 ML InjectionSYa476e063-9450-4793-9a22-16b0a0a61cd04
2675784pantoprazole (as sodium) 40 MG per 50 ML InjectionSYa476e063-9450-4793-9a22-16b0a0a61cd04
2675786pantoprazole (as sodium) 80 MG per 100 ML InjectionSYa476e063-9450-4793-9a22-16b0a0a61cd04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9644-0100338964401100 mL in 1 BAG100 mlHistorical
0338-9644-120033896441212 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01) 12 bag2024-02-14NoNoHistorical