Pantoprazole Sodium

Product NDC
42708-180
11-digit product format
427080180
Labeler code
42708
Product ID
42708-180_459b9dd5-c8d7-be57-e063-6294a90a5cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
QPharma Inc
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-01-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-180-30Pantoprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-180PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [QPHARMA INC]2Current NDC, 1 package rows20240516_fbd035d0-529c-6033-e053-6294a90abf07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNfbd035d0-529c-6033-e053-6294a90abf073
314200pantoprazole 40 MG Delayed Release Oral TabletSCDfbd035d0-529c-6033-e053-6294a90abf073
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYfbd035d0-529c-6033-e053-6294a90abf073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42708-180-304270801803030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42708-180-30) 2023-05-19YesNoHistorical