FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
59651-671
11-digit product format
596510671
Labeler code
59651
Product ID
59651-671_b3cec41e-e98b-470a-8ba2-c31537023989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217923
Marketing category
ANDA
Marketing start
2025-03-31
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
Rxcui763306

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
59651-671-30PANTOPRAZOLE SODIUM1 in 1 PACKETGRANULE, DELAYED RELEASE11
59651-671-30PANTOPRAZOLE SODIUM30 in 1 CARTONGRANULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-671-30EA - Each59651-6715b7c33f7-b5fe-4ad2-bcdf-3fa41eb7af7612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-671PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20250409_b3cec41e-e98b-470a-8ba2-c31537023989.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSNb3cec41e-e98b-470a-8ba2-c315370239891
763306pantoprazole 40 MG Oral GranulesSCDb3cec41e-e98b-470a-8ba2-c315370239891
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSYb3cec41e-e98b-470a-8ba2-c315370239891
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSYb3cec41e-e98b-470a-8ba2-c315370239891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-671-305965106713030 PACKET in 1 CARTON (59651-671-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET30 packet2025-03-31NoNoCurrent