FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
13668-096
11-digit product format
136680096
Labeler code
13668
Product ID
13668-096_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
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
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
13668-096-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-096-05EA - Each13668-096e8ce0a2b-e6c8-45a4-89d8-1c9df81bffc312012-07-24
13668-096-30EA - Each13668-096bbe1964a-3ae5-48bc-910e-55ced26ea5a912012-07-24
13668-096-90EA - Each13668-0968f74e487-b0cb-449f-9f77-3a430b06cc2c12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-096PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]25Current NDC, Legacy NDC, 1 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
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN491102c1-f04b-4b7b-e054-00144ff8d46c3
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole 20 MG Delayed Release Oral TabletSCD491102c1-f04b-4b7b-e054-00144ff8d46c3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY491102c1-f04b-4b7b-e054-00144ff8d46c3
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
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa185b2a1-4406-040c-e053-2a95a90a11912
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN801780eb-30c9-4161-b7b0-e433fd04bc432
251872pantoprazole 20 MG Delayed Release Oral TabletSCD801780eb-30c9-4161-b7b0-e433fd04bc432
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa185b2a1-4406-040c-e053-2a95a90a11912
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
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa185b2a1-4406-040c-e053-2a95a90a11912
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY801780eb-30c9-4161-b7b0-e433fd04bc432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-096-0513668009605500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-096-05) 2011-01-200000-00-00NoNoCurrent
13668-096-301366800963030 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-096-30) 2011-01-200000-00-00NoNoCurrent
13668-096-7413668009674100 TABLET, DELAYED RELEASE in 1 CARTON (13668-096-74) 2011-01-200000-00-00NoNoCurrent
13668-096-901366800969090 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-096-90) 2011-01-200000-00-00NoNoCurrent