FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
13668-429
11-digit product format
136680429
Labeler code
13668
Product ID
13668-429_7d09300f-2078-458c-9328-f83ffd997c9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090074
Marketing category
ANDA
Marketing start
2011-01-20
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
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 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
13668-429-05Pantoprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50027
13668-429-10Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100027
13668-429-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3027
13668-429-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-429-05EA - Each13668-429289bcdb8-c6c2-4b15-976d-20c25edb196112012-07-24
13668-429-30EA - Each13668-429a86ec8f9-4139-4237-89ba-5f209e63fedf12012-07-24
13668-429-90EA - Each13668-429b3be4dfc-e71e-480b-ac59-1df04c56ed4312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
SODIUM CARBONATE DECAHYDRATEINACTIVE INGREDIENTLS505BG22IPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]10
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM CARBONATE DECAHYDRATEINACTIVE INGREDIENTLS505BG22IPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
SODIUM CARBONATE DECAHYDRATEINACTIVE INGREDIENTLS505BG22IPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-429PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]25Current NDC, Legacy NDC, 4 package rows20240706_9c983da1-a8e0-479e-8816-5d5668ea242e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN9c983da1-a8e0-479e-8816-5d5668ea242e27
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9c983da1-a8e0-479e-8816-5d5668ea242e27
251872pantoprazole 20 MG Delayed Release Oral TabletSCD9c983da1-a8e0-479e-8816-5d5668ea242e27
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9c983da1-a8e0-479e-8816-5d5668ea242e27
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY9c983da1-a8e0-479e-8816-5d5668ea242e27
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9c983da1-a8e0-479e-8816-5d5668ea242e27
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9c286e5c-2b36-422b-9f74-e8c0abb3f7479
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9c286e5c-2b36-422b-9f74-e8c0abb3f7479
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9c286e5c-2b36-422b-9f74-e8c0abb3f7479
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN4fbec80c-b38d-122c-e054-00144ff88e884
314200pantoprazole 40 MG Delayed Release Oral TabletSCD4fbec80c-b38d-122c-e054-00144ff88e884
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY4fbec80c-b38d-122c-e054-00144ff88e884
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN73a3cb78-d847-2dda-e053-2a91aa0a284f3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN81696241-17d5-4d35-9e59-8c28469ffd2c3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG Delayed Release Oral TabletSCD73a3cb78-d847-2dda-e053-2a91aa0a284f3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG Delayed Release Oral TabletSCD81696241-17d5-4d35-9e59-8c28469ffd2c3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY81696241-17d5-4d35-9e59-8c28469ffd2c3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY73a3cb78-d847-2dda-e053-2a91aa0a284f3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN801780eb-30c9-4161-b7b0-e433fd04bc432
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN801780eb-30c9-4161-b7b0-e433fd04bc432
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN913221df-021c-e511-e053-2995a90a49482
251872pantoprazole 20 MG Delayed Release Oral TabletSCD801780eb-30c9-4161-b7b0-e433fd04bc432
314200pantoprazole 40 MG Delayed Release Oral TabletSCD913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG Delayed Release Oral TabletSCD914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG Delayed Release Oral TabletSCD801780eb-30c9-4161-b7b0-e433fd04bc432
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY801780eb-30c9-4161-b7b0-e433fd04bc432
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY801780eb-30c9-4161-b7b0-e433fd04bc432
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNac397028-d91b-5089-e053-2a95a90ac0c91
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN095d5a6a-c0da-4026-9779-3be051641f401
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG Delayed Release Oral TabletSCD095d5a6a-c0da-4026-9779-3be051641f401
314200pantoprazole 40 MG Delayed Release Oral TabletSCDac397028-d91b-5089-e053-2a95a90ac0c91
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYac397028-d91b-5089-e053-2a95a90ac0c91
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY095d5a6a-c0da-4026-9779-3be051641f401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-429-0513668042905500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-05) 2011-01-200000-00-00NoNoCurrent
13668-429-10136680429101000 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-10) 2025-11-03NoNoCurrent
13668-429-301366804293030 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-30) 2011-01-200000-00-00NoNoCurrent
13668-429-771366804297780 TABLET, DELAYED RELEASE in 1 CARTON (13668-429-77) 2011-01-200000-00-00NoNoCurrent
13668-429-901366804299090 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-90) 2011-01-200000-00-00NoNoCurrent