FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
60687-736
11-digit product format
606870736
Labeler code
60687
Product ID
60687-736_228dc54a-3313-71e5-e063-6394a90a5bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA202038
Marketing category
ANDA
Marketing start
2023-07-05
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
60687-736-01Pantoprazole Sodium100 in 1 CARTONTABLET, DELAYED RELEASE1002
60687-736-09Pantoprazole Sodium80 in 1 CARTONTABLET, DELAYED RELEASE802
60687-736-11Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12
60687-736-65Pantoprazole Sodium50 in 1 CARTONTABLET, DELAYED RELEASE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-736-01EA - Each60687-7361d27ed34-0697-4140-ab0e-469b2b40603f12023-08-08
60687-736-11EA - Each60687-736f53095e8-a658-4f9c-b8b9-9eaa7f0cdfa812023-08-08
60687-736-65EA - Each60687-736d369b4e6-b5b1-4664-937c-751b993ce07612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-736PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]2Current NDC, 4 package rows20240921_5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-736-0160687073601100 BLISTER PACK in 1 CARTON (60687-736-01) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-736-11) 100 blister pack2023-07-05NoNoCurrent
60687-736-096068707360980 BLISTER PACK in 1 CARTON (60687-736-09) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-736-11) 80 blister pack2023-07-05NoNoCurrent
60687-736-11606870736111 in 1 BLISTER PACKHistorical
60687-736-656068707366550 BLISTER PACK in 1 CARTON (60687-736-65) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-736-11) 50 blister pack2023-07-05NoNoCurrent