FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
72865-230
11-digit product format
728650230
Labeler code
72865
Product ID
72865-230_f26fc428-a419-1008-e053-2a95a90a83fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2022-05-01
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
Rxcui251872, 314200

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
72865-230-10PANTOPRAZOLE SODIUM1000 in 1 BOTTLETABLET, DELAYED RELEASE10003
72865-230-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-230-10EA - Each72865-23042d170ac-6800-4638-9c4c-f1933803c01b12022-07-06
72865-230-90EA - Each72865-2300cb2b300-d409-46f5-b932-84083d99e87212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-230PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [XLCARE PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20230117_17468dbf-84b6-4c53-9ad5-341350d2cfab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN17468dbf-84b6-4c53-9ad5-341350d2cfab3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN17468dbf-84b6-4c53-9ad5-341350d2cfab3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD17468dbf-84b6-4c53-9ad5-341350d2cfab3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD17468dbf-84b6-4c53-9ad5-341350d2cfab3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY17468dbf-84b6-4c53-9ad5-341350d2cfab3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY17468dbf-84b6-4c53-9ad5-341350d2cfab3
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNff15c4f1-8869-4422-9631-dc488e09e5831
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNff15c4f1-8869-4422-9631-dc488e09e5831
251872pantoprazole 20 MG Delayed Release Oral TabletSCDff15c4f1-8869-4422-9631-dc488e09e5831
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1
314200pantoprazole 40 MG Delayed Release Oral TabletSCDff15c4f1-8869-4422-9631-dc488e09e5831
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYff15c4f1-8869-4422-9631-dc488e09e5831
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYff15c4f1-8869-4422-9631-dc488e09e5831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-230-10728650230101000 TABLET, DELAYED RELEASE in 1 BOTTLE (72865-230-10) 2022-05-010000-00-00NoNoCurrent
72865-230-907286502309090 TABLET, DELAYED RELEASE in 1 BOTTLE (72865-230-90) 2022-05-010000-00-00NoNoCurrent