FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50090-3095
11-digit product format
500903095
Labeler code
50090
Product ID
50090-3095_269aa450-1522-4e6b-892a-3f3dbc54d1b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-19
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SO
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inh
NDC exclude flag
No
Listing certified through
2019-12-31
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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3095-0Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3095-0EA - Each50090-30958e647f6c-2afe-41f6-a10b-d7d4a01ae2c012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3095PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 1 package rows20200220_763b2df8-6d83-4d98-b12e-594f45d0aae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3095-05009030950030 in 1 BOTTLEHistorical