FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
71610-653
11-digit product format
716100653
Labeler code
71610
Product ID
71610-653_6c0bca16-d681-48d1-a07a-93d9d0f3acef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2022-05-01
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
71610-653-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
71610-653-53PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE601
71610-653-60PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE901
71610-653-80PANTOPRAZOLE SODIUM180 in 1 BOTTLETABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-653-30EA - Each71610-653e9f12772-de20-4f5c-af4c-48e35da892c912022-09-12
71610-653-53EA - Each71610-6537718384b-a561-4563-aa39-c36fe0bf767f12022-09-12
71610-653-60EA - Each71610-653f6c558bb-7642-490b-a88f-e140e577155512022-09-12
71610-653-80EA - Each71610-653753625ea-c977-4777-b889-7bca7bfa89f812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-653PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20220717_e3f711d8-b9d3-46a6-8bf9-6af1cc77003e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe3f711d8-b9d3-46a6-8bf9-6af1cc77003e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-653-307161006533030 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30) 2022-07-140000-00-00NoNoCurrent
71610-653-537161006535360 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53) 2022-07-140000-00-00NoNoCurrent
71610-653-607161006536090 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60) 2022-07-140000-00-00NoNoCurrent
71610-653-8071610065380180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80) 2022-07-140000-00-00NoNoCurrent