FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
65162-637
11-digit product format
651620637
Labeler code
65162
Product ID
65162-637_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
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65162-637-03Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3018
65162-637-09Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9018
65162-637-11Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100018
65162-637-50Pantoprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-637-09EA - Each65162-637351576dd-ed85-42bd-b87f-8df64f5a73a012016-11-08
65162-637-11EA - Each65162-6371775e498-7220-4243-944a-cbe2986aa25c12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-637PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 4 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
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6d03491f-20c6-4878-9741-2e21e221eff23
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN962951c7-1467-49f7-9ada-361e86fdfcb23
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6d03491f-20c6-4878-9741-2e21e221eff23
314200pantoprazole 40 MG Delayed Release Oral TabletSCD962951c7-1467-49f7-9ada-361e86fdfcb23
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6d03491f-20c6-4878-9741-2e21e221eff23
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY962951c7-1467-49f7-9ada-361e86fdfcb23
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN07d68e39-155f-4816-989c-4df00b5cca4b1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9adbe021-4638-934d-e053-2995a90a5ae91
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9adbe021-4638-934d-e053-2995a90a5ae91
314200pantoprazole 40 MG Delayed Release Oral TabletSCD07d68e39-155f-4816-989c-4df00b5cca4b1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9adbe021-4638-934d-e053-2995a90a5ae91
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY07d68e39-155f-4816-989c-4df00b5cca4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-637-036516206370330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-03) 2016-06-200000-00-00NoNoCurrent
65162-637-096516206370990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09) 2016-06-200000-00-00NoNoCurrent
65162-637-11651620637111000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-11) 2016-06-200000-00-00NoNoCurrent
65162-637-5065162063750500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-50) 2016-06-200000-00-00NoNoCurrent