FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
67296-1230
11-digit product format
672961230
Labeler code
67296
Product ID
67296-1230_d61018ec-f0b8-36df-e053-2995a90a0b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1230-12026-01-29C16284748780-149896155-c9d2-586f-e063-e6dba90add9009d22c7f-c293-9800-e063-6294a90a5fb7
67296-1230-42026-01-29C16284748780-149896155-c9d2-586f-e063-e6dba90add9009d22c7f-c293-9800-e063-6294a90a5fb7
67296-1230-32024-01-30C16284748780-11030e365-3a6a-111a-e063-dadaa90a10e25205ff55-e7aa-01ac-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1230-3Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
67296-1230-1Pantoprazole Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE142
67296-1230-4Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1230PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220121_5205ff55-e7aa-01ac-e054-00144ff8d46c.zip
67296-1230PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REDPHARM DRUG, INC.]2Legacy NDC, 2 package rows20240716_09d22c7f-c293-9800-e063-6294a90a5fb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5205ff55-e7aa-01ac-e054-00144ff8d46c4
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5205ff55-e7aa-01ac-e054-00144ff8d46c4
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5205ff55-e7aa-01ac-e054-00144ff8d46c4
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG Delayed Release Oral TabletSCD09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY09d22c7f-c293-9800-e063-6294a90a5fb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1230-16729612300114 in 1 BOTTLEHistorical
67296-1230-36729612300330 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-1230-3) 2011-01-200000-00-00NoNoCurrent
67296-1230-46729612300430 in 1 BOTTLEHistorical