FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
31722-713
11-digit product format
317220713
Labeler code
31722
Product ID
31722-713_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
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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-713-102021-02-19C16284748780-1ba0f9c33-3be5-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
31722-713-312021-02-19C16284748780-1ba0f9c33-3be5-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
31722-713-322021-02-19C16284748780-1ba0f9c33-3be5-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
31722-713-902021-02-19C16284748780-1ba0f9c33-3be5-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
31722-713-102021-01-29C16284748780-1ba0f9c33-3be5-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
31722-713-312021-01-29C16284748780-1ba0f9c33-3be5-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
31722-713-322021-01-29C16284748780-1ba0f9c33-3be5-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
31722-713-902021-01-29C16284748780-1ba0f9c33-3be5-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
31722-713-10PANTOPRAZOLE SODIUM1000 in 1 BOTTLETABLET, DELAYED RELEASE100014
31722-713-31PANTOPRAZOLE SODIUM10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1014
31722-713-32PANTOPRAZOLE SODIUM10 in 1 CARTONTABLET, DELAYED RELEASE1014
31722-713-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-713-10EA - Each31722-7134edcc0af-d5ce-4c89-b424-a2fb40520df512020-03-10
31722-713-90EA - Each31722-71336f3ef4a-c43e-4514-a1f8-87278d26c57e12015-02-02

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
31722-713PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 4 package rows20240203_9daa1483-5a36-44db-9e0d-904d100da262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc1f37929-a981-4ace-95e6-ae6795a797b317
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc1f37929-a981-4ace-95e6-ae6795a797b317
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc1f37929-a981-4ace-95e6-ae6795a797b317
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN617bb464-5357-472f-8e9d-61aae5b2ebef15
314200pantoprazole 40 MG Delayed Release Oral TabletSCD617bb464-5357-472f-8e9d-61aae5b2ebef15
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY617bb464-5357-472f-8e9d-61aae5b2ebef15
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
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNbd4759ac-46b5-6903-e053-2a95a90a63199
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc89a5396-1d94-c7fa-e053-2995a90a90639
314200pantoprazole 40 MG Delayed Release Oral TabletSCDbd4759ac-46b5-6903-e053-2a95a90a63199
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc89a5396-1d94-c7fa-e053-2995a90a90639
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc89a5396-1d94-c7fa-e053-2995a90a90639
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYbd4759ac-46b5-6903-e053-2a95a90a63199
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3a8fa326-ad75-4b6d-8832-0a2357eeca2f8
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3a8fa326-ad75-4b6d-8832-0a2357eeca2f8
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3a8fa326-ad75-4b6d-8832-0a2357eeca2f8
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa9f32edf-e0b9-4e96-e053-2a95a90afbc85
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN50a278de-bd16-417c-a741-81bfe0d745f25
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNb4a94a37-47c1-4dd9-9e4d-5b4a03480aa65
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa9f32edf-e0b9-4e96-e053-2a95a90afbc85
314200pantoprazole 40 MG Delayed Release Oral TabletSCD50a278de-bd16-417c-a741-81bfe0d745f25
314200pantoprazole 40 MG Delayed Release Oral TabletSCDb4a94a37-47c1-4dd9-9e4d-5b4a03480aa65
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY50a278de-bd16-417c-a741-81bfe0d745f25
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa9f32edf-e0b9-4e96-e053-2a95a90afbc85
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYb4a94a37-47c1-4dd9-9e4d-5b4a03480aa65
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8748a588-a1e5-9dfc-e053-2a95a90a846c3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN0515ceaa-7d17-c92f-e063-6294a90a044e3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD0515ceaa-7d17-c92f-e063-6294a90a044e3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8748a588-a1e5-9dfc-e053-2a95a90a846c3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY8748a588-a1e5-9dfc-e053-2a95a90a846c3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY0515ceaa-7d17-c92f-e063-6294a90a044e3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6a09187d-0859-471b-a283-836a6494757c2
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5c14e2f3-625d-4089-a404-440b0ecf72e72
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6a09187d-0859-471b-a283-836a6494757c2
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5c14e2f3-625d-4089-a404-440b0ecf72e72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5c14e2f3-625d-4089-a404-440b0ecf72e72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6a09187d-0859-471b-a283-836a6494757c2
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN1495af43-0670-e799-e063-6294a90a82a41
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN2644b0ef-07f0-66b9-e063-6394a90a5fa01
251872pantoprazole 20 MG Delayed Release Oral TabletSCD3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD1495af43-0670-e799-e063-6294a90a82a41
314200pantoprazole 40 MG Delayed Release Oral TabletSCD2644b0ef-07f0-66b9-e063-6394a90a5fa01
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
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY2644b0ef-07f0-66b9-e063-6394a90a5fa01
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY1495af43-0670-e799-e063-6294a90a82a41
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe1aa55ec-5e0e-3a58-e053-2a95a90abe4f1
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
31722-713-10317220713101000 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-713-10) 2014-09-100000-00-00NoNoCurrent
31722-713-313172207133110 TABLET, DELAYED RELEASE in 1 BLISTER PACK (31722-713-31) 2014-09-100000-00-00NoNoCurrent
31722-713-323172207133210 TABLET, DELAYED RELEASE in 1 CARTON (31722-713-32) 2014-09-100000-00-00NoNoCurrent
31722-713-903172207139090 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-713-90) 2014-09-100000-00-00NoNoCurrent