FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
62175-617
11-digit product format
621750617
Labeler code
62175
Product ID
62175-617_cfbf12d8-f656-4b99-bd2e-fb11bab669e5
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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-617-43Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100057
62175-617-46Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9057

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-617-43EA - Each62175-61726d846a6-10cf-4ffd-afcf-c40057678ed512015-01-05
62175-617-46EA - Each62175-61761350bea-cc35-472b-a68a-77cc7f50653d12015-01-05

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
62175-617PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LANNETT COMPANY, INC.]57Current NDC, Legacy NDC, 2 package rows20230819_e7705bf6-e473-4b9c-bb5d-57e26ffe7b97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3e5421ef-0875-4a04-b17d-95cca0052c83101
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3e5421ef-0875-4a04-b17d-95cca0052c83101
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3e5421ef-0875-4a04-b17d-95cca0052c83101
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
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG Delayed Release Oral TabletSCDb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYb422c5eb-9a6d-4f8c-863d-ca515ec780c253
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
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG Delayed Release Oral TabletSCDee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5205ff55-e7aa-01ac-e054-00144ff8d46c4
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5205ff55-e7aa-01ac-e054-00144ff8d46c4
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5205ff55-e7aa-01ac-e054-00144ff8d46c4
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
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole 40 MG Delayed Release Oral TabletSCD09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNbb8add3c-11ed-7096-e053-2995a90a323c1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG Delayed Release Oral TabletSCDbb8add3c-11ed-7096-e053-2995a90a323c1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYbb8add3c-11ed-7096-e053-2995a90a323c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-617-43621750617431000 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-617-43) 2011-01-200000-00-00NoNoCurrent
62175-617-466217506174690 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-617-46) 2011-01-200000-00-00NoNoCurrent