FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0378-6688
11-digit product format
003786688
Labeler code
0378
Product ID
0378-6688_38896560-f523-4d0b-8113-5ff7f5f38c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-01-19
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6688-77Pantoprazole Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9018
0378-6688-99Pantoprazole Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6688-77EA - Each0378-6688bf5682fb-69cb-4ef5-88c5-7aa8909a247212012-07-24
0378-6688-99EA - Each0378-6688058efdbc-16b5-404d-b4a2-c28f7d8b020912020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6688PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20230923_56ad5b97-8e5f-48a5-b2ba-a5484b43d018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
251872pantoprazole 20 MG Delayed Release Oral TabletSCD56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
314200pantoprazole 40 MG Delayed Release Oral TabletSCD56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY56ad5b97-8e5f-48a5-b2ba-a5484b43d01818
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd27e1fdd-e23f-0d60-e053-2a95a90a90875
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd27e1fdd-e23f-0d60-e053-2a95a90a90875
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd27e1fdd-e23f-0d60-e053-2a95a90a90875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6688-770037866887790 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6688-77) 2011-01-190000-00-00NoNoCurrent
0378-6688-990037866889990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6688-99) 2020-02-192023-01-31NoNoCurrent