FDA.reportPublic FDA data

Pantoprazole

Product NDC
68071-3776
11-digit product format
680713776
Labeler code
68071
Product ID
68071-3776_2cdd5c73-14c7-6010-e063-6394a90a83a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA077619
Marketing category
ANDA
Marketing start
2023-12-15
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
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
68071-3776-3Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE302
68071-3776-6Pantoprazole60 in 1 BOTTLETABLET, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3776PANTOPRAZOLE TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250130_2bed1bae-519f-1bb9-e063-6294a90a795b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN2bed1bae-519f-1bb9-e063-6294a90a795b2
251872pantoprazole 20 MG Delayed Release Oral TabletSCD2bed1bae-519f-1bb9-e063-6294a90a795b2
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY2bed1bae-519f-1bb9-e063-6294a90a795b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3776-36807137760330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3776-3) 2025-01-29NoNoHistorical
68071-3776-66807137760660 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3776-6) 2025-01-17NoNoHistorical