FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
83008-034
11-digit product format
830080034
Labeler code
83008
Product ID
83008-034_ac72a3f6-4db4-4ce6-a1ec-8e2fa428448d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA202038
Marketing category
ANDA
Marketing start
2023-07-18
Marketing end
2027-03-31
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872

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
83008-034-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303
83008-034-60Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-034PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [QUALITY CARE PRODUCTS, LLC]3Current NDC, 2 package rows20241222_a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-034-308300800343030 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-30) 2023-07-182027-01-31NoNoHistorical
83008-034-608300800346060 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-60) 2023-07-182027-03-31NoNoHistorical