FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
31722-032
11-digit product format
317220032
Labeler code
31722
Product ID
31722-032_092a2d03-1a01-a7ac-e063-6394a90a01b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216139
Marketing category
ANDA
Marketing start
2023-10-27
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
Rxcui763306

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
31722-032-32Pantoprazole Sodium1 in 1 PACKETGRANULE, DELAYED RELEASE11
31722-032-32Pantoprazole Sodium30 in 1 CARTONGRANULE, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-032PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20231103_ee6278c0-d8c0-417c-a65c-b522ff76fe44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSNee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG Oral GranulesSCDee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSYee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSYee6278c0-d8c0-417c-a65c-b522ff76fe441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-032-323172200323230 PACKET in 1 CARTON (31722-032-32) / 1 GRANULE, DELAYED RELEASE in 1 PACKET30 packet2023-10-27NoNoCurrent