FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
42799-952
11-digit product format
427990952
Labeler code
42799
Product ID
42799-952_27c1732b-93f7-4c6c-941b-57223d7238ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA216247
Marketing category
ANDA
Marketing start
2023-06-16
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
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
42799-952-01Pantoprazole Sodium1 in 1 PACKETGRANULE, DELAYED RELEASE14
42799-952-30Pantoprazole Sodium30 in 1 CARTONGRANULE, DELAYED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-952-01EA - Each42799-952a200ed55-600b-4525-9427-aa61691d54c412023-09-05
42799-952-30EA - Each42799-9527025722f-4af1-4160-b76d-87fe576e61fd12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-952PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 2 package rows20230912_a0bb76bc-094a-4d61-9bb2-2226c9da4ae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSNa0bb76bc-094a-4d61-9bb2-2226c9da4ae94
763306pantoprazole 40 MG Oral GranulesSCDa0bb76bc-094a-4d61-9bb2-2226c9da4ae94
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSYa0bb76bc-094a-4d61-9bb2-2226c9da4ae94
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSYa0bb76bc-094a-4d61-9bb2-2226c9da4ae94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-952-01427990952011 in 1 PACKETHistorical
42799-952-304279909523030 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01) 30 packet2023-08-15NoNoCurrent