FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
31722-712
11-digit product format
317220712
Labeler code
31722
Product ID
31722-712_48f42a12-2eac-e5dd-e063-6294a90aa92d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-712-312021-02-19C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
31722-712-322021-02-19C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
31722-712-902021-02-19C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
31722-712-312021-01-29C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
31722-712-322021-01-29C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
31722-712-902021-01-29C16284748780-1ba0f9c33-3be5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-712-31PANTOPRAZOLE SODIUM10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1014
31722-712-32PANTOPRAZOLE SODIUM10 in 1 CARTONTABLET, DELAYED RELEASE1014
31722-712-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-712-90EA - Each31722-712667137d8-dc16-4931-a65d-1a9e612ee21412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (Type H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-712PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20240203_9daa1483-5a36-44db-9e0d-904d100da262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106
251872pantoprazole 20 MG Delayed Release Oral TabletSCDfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN9daa1483-5a36-44db-9e0d-904d100da26214
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9daa1483-5a36-44db-9e0d-904d100da26214
251872pantoprazole 20 MG Delayed Release Oral TabletSCD9daa1483-5a36-44db-9e0d-904d100da26214
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9daa1483-5a36-44db-9e0d-904d100da26214
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY9daa1483-5a36-44db-9e0d-904d100da26214
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9daa1483-5a36-44db-9e0d-904d100da26214
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN39ba58cc-e4ef-4b82-a0f3-9583fa123a387
251872pantoprazole 20 MG Delayed Release Oral TabletSCD39ba58cc-e4ef-4b82-a0f3-9583fa123a387
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY39ba58cc-e4ef-4b82-a0f3-9583fa123a387
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNda67e1c0-9947-957d-e053-2a95a90ad96d4
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb2abc159-e450-99dc-e053-2a95a90abe6a4
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa7e7c1ab-3e75-1ff8-e053-2995a90a75394
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa7e7c1ab-3e75-1ff8-e053-2995a90a75394
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb2abc159-e450-99dc-e053-2a95a90abe6a4
251872pantoprazole 20 MG Delayed Release Oral TabletSCDda67e1c0-9947-957d-e053-2a95a90ad96d4
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa7e7c1ab-3e75-1ff8-e053-2995a90a75394
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb2abc159-e450-99dc-e053-2a95a90abe6a4
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYda67e1c0-9947-957d-e053-2a95a90ad96d4
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf5c9e3c6-d4b0-0ebe-e053-2995a90abe553
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdce2e97a-cd92-46b9-9444-91739bdcd5263
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf5c9e3c6-d4b0-0ebe-e053-2995a90abe553
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdce2e97a-cd92-46b9-9444-91739bdcd5263
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf5c9e3c6-d4b0-0ebe-e053-2995a90abe553
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdce2e97a-cd92-46b9-9444-91739bdcd5263
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN89bfb7f7-6366-4ea4-a1ac-e8f22875f56a2
251872pantoprazole 20 MG Delayed Release Oral TabletSCD89bfb7f7-6366-4ea4-a1ac-e8f22875f56a2
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY89bfb7f7-6366-4ea4-a1ac-e8f22875f56a2
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb0f40e59-37ce-df8b-e053-2995a90a01ce1
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1d51ffeb-21ef-e2b5-e063-6294a90a00dd1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG Delayed Release Oral TabletSCD3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb0f40e59-37ce-df8b-e053-2995a90a01ce1
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1d51ffeb-21ef-e2b5-e063-6294a90a00dd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb0f40e59-37ce-df8b-e053-2995a90a01ce1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1d51ffeb-21ef-e2b5-e063-6294a90a00dd1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3540d01c-da0e-477e-9e90-994b96deb1d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-712-313172207123110 TABLET, DELAYED RELEASE in 1 BLISTER PACK (31722-712-31) 2014-09-100000-00-00NoNoCurrent
31722-712-323172207123210 TABLET, DELAYED RELEASE in 1 CARTON (31722-712-32) 2014-09-100000-00-00NoNoCurrent
31722-712-903172207129090 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-712-90) 2014-09-100000-00-00NoNoCurrent