FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
42708-185
11-digit product format
427080185
Labeler code
42708
Product ID
42708-185_518fad79-032b-17c9-e063-6394a90ab708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
QPharma Inc
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-185-30Pantoprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-185PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [QPHARMA INC]1Current NDC, 1 package rows20240111_0e200326-8885-18d0-e063-6294a90aad2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN0e200326-8885-18d0-e063-6294a90aad2f3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD0e200326-8885-18d0-e063-6294a90aad2f3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY0e200326-8885-18d0-e063-6294a90aad2f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42708-185-304270801853030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42708-185-30) 2024-01-12YesNoCurrent