FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
82009-010
11-digit product format
820090010
Labeler code
82009
Product ID
82009-010_48430767-cec0-15e0-e063-6394a90ac032
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2022-06-06
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, 314200

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
82009-010-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-010-90EA - Each82009-01037d9dba8-ca1a-4bdb-b0cf-6ea06f95f3e012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-010PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20240815_643eb498-d916-4fb7-9281-32895575ab36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN643eb498-d916-4fb7-9281-32895575ab364
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN643eb498-d916-4fb7-9281-32895575ab364
251872pantoprazole 20 MG Delayed Release Oral TabletSCD643eb498-d916-4fb7-9281-32895575ab364
314200pantoprazole 40 MG Delayed Release Oral TabletSCD643eb498-d916-4fb7-9281-32895575ab364
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY643eb498-d916-4fb7-9281-32895575ab364
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY643eb498-d916-4fb7-9281-32895575ab364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-010-908200900109090 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-010-90) 2022-06-060000-00-00NoNoCurrent