FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0093-0012
11-digit product format
000930012
Labeler code
0093
Product ID
0093-0012_52af0bfa-72d0-484f-890a-ca5524194446
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-19
Marketing end
2020-05-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0012-98EA - Each0093-00121c371f1c-ea9d-4350-8844-d2d093cd868312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN69fd1b28-9e57-4ac6-b04d-3dd8da8a91aa3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD69fd1b28-9e57-4ac6-b04d-3dd8da8a91aa3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY69fd1b28-9e57-4ac6-b04d-3dd8da8a91aa3
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf9be6294-9a16-4de1-b346-af0d09a974822
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNf9be6294-9a16-4de1-b346-af0d09a974822
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf9be6294-9a16-4de1-b346-af0d09a974822
314200pantoprazole 40 MG Delayed Release Oral TabletSCDf9be6294-9a16-4de1-b346-af0d09a974822
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf9be6294-9a16-4de1-b346-af0d09a974822
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYf9be6294-9a16-4de1-b346-af0d09a974822
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa81dc60e-af42-4d5a-ba21-865fec74ce051
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa81dc60e-af42-4d5a-ba21-865fec74ce051
314200pantoprazole 40 MG Delayed Release Oral TabletSCD59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa81dc60e-af42-4d5a-ba21-865fec74ce051
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11