FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
50090-5794
11-digit product format
500905794
Labeler code
50090
Product ID
50090-5794_2e3af5aa-2ecf-42b3-944e-ce46273f8349
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
Rxcui314200

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5794-02023-02-06C16284748780-1f386c64a-38e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5794-12023-02-06C16284748780-1f386c64a-38e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5794-02023-01-30C16284748780-1f386c64a-38e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5794-12023-01-30C16284748780-1f386c64a-38e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5794-0PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE308
50090-5794-1PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5794-0EA - Each50090-5794667f7045-2701-4ec3-9ee5-717554413e0f12022-12-07
50090-5794-1EA - Each50090-5794db75d286-e979-4871-b12b-bd73e041ae2212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5794PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240426_3a8fa326-ad75-4b6d-8832-0a2357eeca2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3a8fa326-ad75-4b6d-8832-0a2357eeca2f8
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3a8fa326-ad75-4b6d-8832-0a2357eeca2f8
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3a8fa326-ad75-4b6d-8832-0a2357eeca2f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5794-05009057940030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5794-0) 2021-10-110000-00-00NoNoCurrent
50090-5794-15009057940190 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5794-1) 2021-10-110000-00-00NoNoCurrent