FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
61919-599
11-digit product format
619190599
Labeler code
61919
Product ID
61919-599_94e5199a-db4f-a54f-e053-2995a90a5cbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077056
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-599-302023-01-30C16284748780-1f386c649-d6a8-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM
61919-599-402023-01-30C16284748780-1f386c649-d6a8-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM
61919-599-602023-01-30C16284748780-1f386c649-d6a8-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM
61919-599-902023-01-30C16284748780-1f386c649-d6a8-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-599-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE303
61919-599-40PANTOPRAZOLE SODIUM40 in 1 BOTTLETABLET, DELAYED RELEASE403
61919-599-60PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE603
61919-599-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]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
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]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
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-599PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]3Legacy NDC, 4 package rows20191015_69fd1b28-9e57-4ac6-b04d-3dd8da8a91aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-599-306191905993030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-599-30) 2014-01-010000-00-00NoNoCurrent
61919-599-406191905994040 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-599-40) 2014-01-010000-00-00NoNoCurrent
61919-599-606191905996060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-599-60) 2014-01-010000-00-00NoNoCurrent
61919-599-906191905999090 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-599-90) 2014-01-010000-00-00NoNoCurrent