FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
65862-559
11-digit product format
658620559
Labeler code
65862
Product ID
65862-559_4784124c-9df4-42f6-8044-c0480c1a3bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
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 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
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
65862-559-10Pantoprazole Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1024
65862-559-10Pantoprazole Sodium10 in 1 CARTONTABLET, DELAYED RELEASE1024
65862-559-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9024
65862-559-99Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-559-90EA - Each65862-55983395f2b-8057-4b28-9e21-e022588d032212013-06-04
65862-559-99EA - Each65862-559a4b3ea75-b090-4d0f-901d-e4ca41c0ffdf12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-559PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]22Current NDC, Legacy NDC, 4 package rows20240218_7418f358-f536-4de6-adf0-562b4373f2e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole 20 MG Delayed Release Oral TabletSCD03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole 20 MG Delayed Release Oral TabletSCD7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole 20 MG Delayed Release Oral TabletSCD76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG Delayed Release Oral TabletSCD517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY517d6b02-0e68-4d6b-98b3-eac0be457e6b9
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
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole 20 MG Delayed Release Oral TabletSCD924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1c46140c-2399-5ca3-e063-6394a90af33b1
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf92276a1-b286-489d-a372-f441e49cfd631
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG Delayed Release Oral TabletSCD138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf92276a1-b286-489d-a372-f441e49cfd631
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1c46140c-2399-5ca3-e063-6394a90af33b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1c46140c-2399-5ca3-e063-6394a90af33b1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf92276a1-b286-489d-a372-f441e49cfd631
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY138b30cb-6b28-450e-9e7a-42576cc765451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-559-106586205591010 BLISTER PACK in 1 CARTON (65862-559-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2012-09-280000-00-00NoNoCurrent
65862-559-556586205595515000 TABLET, DELAYED RELEASE in 1 BAG (65862-559-55)28-SEP-12Current
65862-559-906586205599090 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-559-90) 2012-09-280000-00-00NoNoCurrent
65862-559-99658620559991000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-559-99) 2012-09-280000-00-00NoNoCurrent