FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
72603-128
11-digit product format
726030128
Labeler code
72603
Product ID
72603-128_e74d873e-138b-4ba4-ba33-05a0998dc45d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA215860
Marketing category
ANDA
Marketing start
2022-08-29
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/10mL
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/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui283669

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
72603-128-01Pantoprazole Sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION103
72603-128-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-128-01EA - Each72603-128c0209335-674f-41e8-9968-955287cce42912022-12-07
72603-128-10EA - Each72603-12846c8c721-8521-41f0-aa20-39dd9abe2db412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-128PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 2 package rows20231117_7e0c5dac-6832-4692-b012-ca59d5e88987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN7e0c5dac-6832-4692-b012-ca59d5e889873
283669pantoprazole 40 MG InjectionSCD7e0c5dac-6832-4692-b012-ca59d5e889873
283669pantoprazole (as sodium) 40 MG InjectionSY7e0c5dac-6832-4692-b012-ca59d5e889873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-128-017260301280110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72603-128-107260301281010 VIAL, SINGLE-DOSE in 1 CARTON (72603-128-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-128-01) 2022-08-290000-00-00NoNoCurrent