PANTOPRAZOLE SODIUM

Product NDC
51655-744
11-digit product format
516550744
Labeler code
51655
Product ID
51655-744_49515c4d-33ac-58d7-e063-6394a90aa2cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2021-07-09
Substance
PANTOPRAZOLE SODIUM
Active strength
20 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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872

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
51655-744-52PANTOPRAZOLE SODIUM30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-744PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241228_da67e1c0-9947-957d-e053-2a95a90ad96d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNda67e1c0-9947-957d-e053-2a95a90ad96d4
251872pantoprazole 20 MG Delayed Release Oral TabletSCDda67e1c0-9947-957d-e053-2a95a90ad96d4
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYda67e1c0-9947-957d-e053-2a95a90ad96d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-744-525165507445230 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-744-52) 2021-07-09NoNoHistorical