PANTOPRAZOLE SODIUM

Product NDC
60760-679
11-digit product format
607600679
Labeler code
60760
Product ID
60760-679_e1aa611e-7960-a074-e053-2a95a90a914e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA202882
Marketing category
ANDA
Marketing start
2022-03-01
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
60760-679-30PANTOPRAZOLE SODIUM30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-679-30EA - Each60760-6796e5f9795-4ffc-415b-8b6c-1fdd773a521b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-679PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [ST MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20220619_e1aa55ec-5e0e-3a58-e053-2a95a90abe4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-679-306076006793030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-679-30) 2022-03-010000-00-00NoNoCurrent