FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
62756-071
11-digit product format
627560071
Labeler code
62756
Product ID
62756-071_d19d65d9-7bab-4a6f-9a79-ed3d32bd83d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA213725
Marketing category
ANDA
Marketing start
2020-07-01
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
62756-071-60PANTOPRAZOLE SODIUM1 in 1 PACKETGRANULE, DELAYED RELEASE15
62756-071-64PANTOPRAZOLE SODIUM30 in 1 CARTONGRANULE, DELAYED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-071PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 2 package rows20230817_38353b9e-63bd-47e8-b7cb-b198d1e901f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN38353b9e-63bd-47e8-b7cb-b198d1e901f95
763306pantoprazole 40 MG Oral GranulesSCD38353b9e-63bd-47e8-b7cb-b198d1e901f95
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY38353b9e-63bd-47e8-b7cb-b198d1e901f95
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY38353b9e-63bd-47e8-b7cb-b198d1e901f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-071-60627560071601 in 1 PACKETHistorical
62756-071-646275600716430 PACKET in 1 CARTON (62756-071-64) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (62756-071-60) 30 packet2020-07-010000-00-00NoNoCurrent