FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
65162-636
11-digit product format
651620636
Labeler code
65162
Product ID
65162-636_774b587f-7d77-4d2e-97f6-2b19d8cec56a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
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, 314200

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
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
65162-636-03Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3018
65162-636-09Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-636-09EA - Each65162-636716a7184-3879-4088-b670-6f1718b1e28812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-636PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 2 package rows20250124_f3ded82a-cf0d-4844-944a-75f9f9215ff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole 40 MG Delayed Release Oral TabletSCDf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG Delayed Release Oral TabletSCD440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY440b9ae8-2fb8-5d35-e063-6294a90a82b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-636-036516206360330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-03) 2016-06-200000-00-00NoNoCurrent
65162-636-096516206360990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-09) 2016-06-200000-00-00NoNoCurrent