FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50268-639
11-digit product format
502680639
Labeler code
50268
Product ID
50268-639_47fb0652-007e-e12b-e063-6294a90ab81a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA078281
Marketing category
ANDA
Marketing start
2015-02-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-639-11Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE113
50268-639-15Pantoprazole Sodium50 in 1 BOXTABLET, DELAYED RELEASE5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-639-11EA - Each50268-6396c10eb8a-cf79-4dfb-bda3-5e61356e48cd12015-11-12
50268-639-15EA - Each50268-639b539062b-3f79-4c16-8781-7c828825138612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
50268-639PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AVPAK]12Current NDC, Legacy NDC, 2 package rows20220913_dcac4022-fea1-67c5-3331-fefcc3c440d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-639-11502680639111 in 1 BLISTER PACKHistorical
50268-639-155026806391550 BLISTER PACK in 1 BOX (50268-639-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-639-11) 50 blister pack2015-02-190000-00-00NoNoCurrent