FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
72205-180
11-digit product format
722050180
Labeler code
72205
Product ID
72205-180_1172bc4e-1700-402f-8262-97f05bac0d09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216171
Marketing category
ANDA
Marketing start
2022-05-19
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
72205-180-01Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION101
72205-180-07Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
72205-180-09Pantoprazole Sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-180PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 3 package rows20220520_1172bc4e-1700-402f-8262-97f05bac0d09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN1172bc4e-1700-402f-8262-97f05bac0d091
283669pantoprazole 40 MG InjectionSCD1172bc4e-1700-402f-8262-97f05bac0d091
283669pantoprazole (as sodium) 40 MG InjectionSY1172bc4e-1700-402f-8262-97f05bac0d091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-180-017220501800110 mL in 1 VIAL10 mlHistorical
72205-180-077220501800710 VIAL in 1 CARTON (72205-180-07) / 10 mL in 1 VIAL (72205-180-01) 10 vial2022-05-190000-00-00NoNoCurrent
72205-180-097220501800925 VIAL in 1 CARTON (72205-180-09) / 10 mL in 1 VIAL (72205-180-01) 25 vial2022-05-190000-00-00NoNoCurrent