FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0615-8113
11-digit product format
006158113
Labeler code
0615
Product ID
0615-8113_ee95d143-2812-493e-85ec-1dd0deb22990
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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 Sodium
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8113-05Pantoprazole Sodium15 in 1 BLISTER PACKTABLET, DELAYED RELEASE158
0615-8113-39Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8113PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 2 package rows20240614_1680b4ed-d5b0-4fd9-b1d1-04df6a2138be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8113-050061581130515 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-05) 2022-12-15NoNoCurrent
0615-8113-390061581133930 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-39) 2018-11-070000-00-00NoNoCurrent