FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
73043-020
11-digit product format
730430020
Labeler code
73043
Product ID
73043-020_ee61b559-2d9b-4202-b9de-e37ce3733019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Devatis Inc.
Application
ANDA215074
Marketing category
ANDA
Marketing start
2025-08-01
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
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/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
73043-020-01Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-01Pantoprazole Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12
73043-020-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
73043-020-10Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-25Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-25Pantoprazole Sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-020-01EA - Each73043-020a35607f3-1cd5-4e22-b133-ac5bc344265712025-09-12
73043-020-10EA - Each73043-02041f79146-1d44-4b55-861b-a8b50e6a143812025-09-12
73043-020-25EA - Each73043-020d71e367e-69f4-4fea-87d0-a1a2cb1e57bc12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN13c337e7-1e7b-47bd-9f88-92b0d548ca9c2
283669pantoprazole 40 MG InjectionSCD13c337e7-1e7b-47bd-9f88-92b0d548ca9c2
283669pantoprazole (as sodium) 40 MG InjectionSY13c337e7-1e7b-47bd-9f88-92b0d548ca9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-020-01730430020011 VIAL in 1 CARTON (73043-020-01) / 10 mL in 1 VIAL1 vial2025-08-01NoNoCurrent
73043-020-107304300201010 VIAL in 1 CARTON (73043-020-10) / 10 mL in 1 VIAL10 vial2025-08-01NoNoCurrent
73043-020-257304300202525 VIAL in 1 CARTON (73043-020-25) / 10 mL in 1 VIAL25 vial2025-08-01NoNoCurrent