FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
62175-180
11-digit product format
621750180
Labeler code
62175
Product ID
62175-180_07758068-a10d-4a90-9721-eb8ed6636c52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
2023-03-31
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-180-43Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100057
62175-180-46Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9057

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-180-46EA - Each62175-180cb2316b0-aeab-444b-a3c5-964cbe049df912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
crospovidoneINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
isopropyl alcoholINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
talcINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-180PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LANNETT COMPANY, INC.]57Legacy NDC, 2 package rows20230819_e7705bf6-e473-4b9c-bb5d-57e26ffe7b97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNdcac4022-fea1-67c5-3331-fefcc3c440d813
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole 40 MG Delayed Release Oral TabletSCDdcac4022-fea1-67c5-3331-fefcc3c440d813
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYdcac4022-fea1-67c5-3331-fefcc3c440d813
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa824b04e-16a2-28f4-e053-2a95a90ab8bb1
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa824b04e-16a2-28f4-e053-2a95a90ab8bb1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa824b04e-16a2-28f4-e053-2a95a90ab8bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-180-43621750180431000 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-180-43) 2011-01-202023-03-31NoNoCurrent
62175-180-466217501804690 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-180-46) 2011-01-202023-03-31NoNoCurrent