FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
62135-534
11-digit product format
621350534
Labeler code
62135
Product ID
62135-534_4687aefe-4974-b8d6-e063-6294a90a0522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-534-08Pantoprazole Sodium450 in 1 BOTTLETABLET, DELAYED RELEASE4503
62135-534-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-534-08EA - Each62135-534e032ec5f-87a0-461a-ad7a-6a51eca788d412023-05-05
62135-534-90EA - Each62135-534d0bd1f49-bfb0-4fea-a192-aa5253c4e8e112023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-534PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CHARTWELL RX, LLC]2Current NDC, 2 package rows20241025_42a969c3-1144-4151-9cf3-3e9bace6a380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN42a969c3-1144-4151-9cf3-3e9bace6a3803
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN42a969c3-1144-4151-9cf3-3e9bace6a3803
251872pantoprazole 20 MG Delayed Release Oral TabletSCD42a969c3-1144-4151-9cf3-3e9bace6a3803
314200pantoprazole 40 MG Delayed Release Oral TabletSCD42a969c3-1144-4151-9cf3-3e9bace6a3803
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY42a969c3-1144-4151-9cf3-3e9bace6a3803
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY42a969c3-1144-4151-9cf3-3e9bace6a3803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-534-0862135053408450 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-08) 2023-04-05NoNoHistorical
62135-534-906213505349090 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-90) 2023-04-05NoNoHistorical