FDA.reportPublic FDA data

Pantoprazole

Product NDC
55111-333
11-digit product format
551110333
Labeler code
55111
Product ID
55111-333_c0575fc6-20c4-12a6-10b7-1af65cac1ee0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA077619
Marketing category
ANDA
Marketing start
2011-01-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole
Listing expiration
2027-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-333-01Pantoprazole100 in 1 BOTTLETABLET, DELAYED RELEASE10021
55111-333-05Pantoprazole500 in 1 BOTTLETABLET, DELAYED RELEASE50021
55111-333-10Pantoprazole1000 in 1 BOTTLETABLET, DELAYED RELEASE100021
55111-333-30Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE3021
55111-333-78Pantoprazole10 in 1 CARTONTABLET, DELAYED RELEASE1021
55111-333-79Pantoprazole10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1021
55111-333-81Pantoprazole3 in 1 CARTONTABLET, DELAYED RELEASE321
55111-333-90Pantoprazole90 in 1 BOTTLETABLET, DELAYED RELEASE9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-333-90EA - Each55111-33398cee126-65ba-46e8-ad41-1c45527d3d6112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pantoprazole sodiumACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
PantoprazoleACTIVE MOIETYD8TST4O562PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
ZEININACTIVE INGREDIENT80N308T1NNPANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]11
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZEININACTIVE INGREDIENT80N308T1NNPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-333PANTOPRAZOLE TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]20Current NDC, Legacy NDC, 8 package rows20231212_564709e8-358f-c185-4ecb-b3849c3fe59c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN564709e8-358f-c185-4ecb-b3849c3fe59c21
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN564709e8-358f-c185-4ecb-b3849c3fe59c21
251872pantoprazole 20 MG Delayed Release Oral TabletSCD564709e8-358f-c185-4ecb-b3849c3fe59c21
314200pantoprazole 40 MG Delayed Release Oral TabletSCD564709e8-358f-c185-4ecb-b3849c3fe59c21
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY564709e8-358f-c185-4ecb-b3849c3fe59c21
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY564709e8-358f-c185-4ecb-b3849c3fe59c21
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN07ff83f9-7039-ac26-e063-6394a90a37ce2
314200pantoprazole 40 MG Delayed Release Oral TabletSCD07ff83f9-7039-ac26-e063-6394a90a37ce2
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY07ff83f9-7039-ac26-e063-6394a90a37ce2
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNea505b23-b997-43d5-e053-2995a90a098f1
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG Delayed Release Oral TabletSCDdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG Delayed Release Oral TabletSCDea505b23-b997-43d5-e053-2995a90a098f1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYea505b23-b997-43d5-e053-2995a90a098f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-333-0155111033301100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-01) 2011-01-190000-00-00NoNoCurrent
55111-333-0555111033305500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-05) 2011-01-190000-00-00NoNoCurrent
55111-333-10551110333101000 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-10) 2026-05-010000-00-00NoNoCurrent
55111-333-305511103333030 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-30) 2011-01-190000-00-00NoNoCurrent
55111-333-785511103337810 BLISTER PACK in 1 CARTON (55111-333-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-333-79) 10 blister pack2011-01-190000-00-00NoNoCurrent
55111-333-795511103337910 in 1 BLISTER PACKHistorical
55111-333-81551110333813 BLISTER PACK in 1 CARTON (55111-333-81) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-333-79) 3 blister pack2011-01-190000-00-00NoNoCurrent
55111-333-905511103339090 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-333-90) 2011-01-190000-00-00NoNoCurrent