FDA.reportPublic FDA data

Pantoprazole

Product NDC
60760-574
11-digit product format
607600574
Labeler code
60760
Product ID
60760-574_45381395-cf3f-23fe-e063-6394a90a13df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA077619
Marketing category
ANDA
Marketing start
2022-10-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole
Listing expiration
2026-12-31

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
60760-574-30Pantoprazole30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE303
60760-574-60Pantoprazole60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-574-30EA - Each60760-5747d38ba49-52c1-4d92-b6f7-cdd99b7b13cc12023-10-16
60760-574-60EA - Each60760-5741eab7a72-2139-4bad-b56b-d4db5cbb4ffc12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-574PANTOPRAZOLE TABLET, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20230913_ed264262-21bb-1bae-e053-2995a90a8a5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNed264262-21bb-1bae-e053-2995a90a8a5e3
251872pantoprazole 20 MG Delayed Release Oral TabletSCDed264262-21bb-1bae-e053-2995a90a8a5e3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYed264262-21bb-1bae-e053-2995a90a8a5e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-574-306076005743030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-574-30) 2023-08-29NoNoHistorical
60760-574-606076005746060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-574-60) 2022-10-310000-00-00NoNoCurrent