FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
72603-317
11-digit product format
726030317
Labeler code
72603
Product ID
72603-317_4494f9d0-a1c8-477f-9b4a-f65d7637d9ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA213725
Marketing category
ANDA
Marketing start
2024-10-01
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
72603-317-01PANTOPRAZOLE SODIUM1 in 1 PACKETGRANULE, DELAYED RELEASE11
72603-317-30PANTOPRAZOLE SODIUM30 in 1 CARTONGRANULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-317-01EA - Each72603-31733e0c50f-7796-4d8b-a334-0e13619a126f12024-12-10
72603-317-30EA - Each72603-3172f4faed7-525c-4a8a-b1fe-e1bb396b3fc912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-317PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [NORTHSTAR RXLLC]1Current NDC, 2 package rows20241001_4494f9d0-a1c8-477f-9b4a-f65d7637d9ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN4494f9d0-a1c8-477f-9b4a-f65d7637d9ec1
763306pantoprazole 40 MG Oral GranulesSCD4494f9d0-a1c8-477f-9b4a-f65d7637d9ec1
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY4494f9d0-a1c8-477f-9b4a-f65d7637d9ec1
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY4494f9d0-a1c8-477f-9b4a-f65d7637d9ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-317-01726030317011 in 1 PACKETHistorical
72603-317-307260303173030 PACKET in 1 CARTON (72603-317-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (72603-317-01) 30 packet2024-10-01NoNoCurrent