FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
70518-0860
11-digit product format
705180860
Labeler code
70518
Product ID
70518-0860_4d39b64c-2e2b-afed-e063-6394a90a3812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202038
Marketing category
ANDA
Marketing start
2017-11-20
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
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 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
70518-0860-0Pantoprazole Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9019
70518-0860-1Pantoprazole Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE2819

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0860PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 2 package rows20250507_f313159c-115a-4cf6-b32e-9ddc833fd51c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNf313159c-115a-4cf6-b32e-9ddc833fd51c19
314200pantoprazole 40 MG Delayed Release Oral TabletSCDf313159c-115a-4cf6-b32e-9ddc833fd51c19
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYf313159c-115a-4cf6-b32e-9ddc833fd51c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0860-07051808600090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0860-0) 2017-11-200000-00-00NoNoCurrent
70518-0860-17051808600128 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-0860-1) 2018-09-260000-00-00NoNoCurrent