FDA.reportPublic FDA data

Pantoprazole sodium

Product NDC
60687-767
11-digit product format
606870767
Labeler code
60687
Product ID
60687-767_236c62bf-3ddb-0b3e-e063-6394a90ad6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA217416
Marketing category
ANDA
Marketing start
2023-08-01
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
60687-767-27Pantoprazole sodium30 in 1 CARTONFOR SUSPENSION302
60687-767-99Pantoprazole sodium1 in 1 PACKETFOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-767-27EA - Each60687-7679d231460-bddb-4d40-99b0-3538e3595beb12023-09-05
60687-767-99EA - Each60687-7678ae04873-44b9-4bec-9f13-30f911b8e64612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-767PANTOPRAZOLE SODIUM FOR SUSPENSION [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20241004_423dac8b-bb1e-4456-9b6e-913c028b11bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN423dac8b-bb1e-4456-9b6e-913c028b11bc2
763306pantoprazole 40 MG Oral GranulesSCD423dac8b-bb1e-4456-9b6e-913c028b11bc2
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY423dac8b-bb1e-4456-9b6e-913c028b11bc2
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY423dac8b-bb1e-4456-9b6e-913c028b11bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-767-276068707672730 PACKET in 1 CARTON (60687-767-27) / 1 FOR SUSPENSION in 1 PACKET (60687-767-99) 30 packet2023-08-01NoNoCurrent
60687-767-99606870767991 in 1 PACKETHistorical