FDA.reportPublic FDA data

Pantoprazole sodium

Product NDC
71839-122
11-digit product format
718390122
Labeler code
71839
Product ID
71839-122_bad4fab9-654b-423c-87dc-25ff7a9f29d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA216171
Marketing category
ANDA
Marketing start
2022-05-25
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
71839-122-01Pantoprazole sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION104
71839-122-01Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
71839-122-10Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
71839-122-10Pantoprazole sodium10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION104
71839-122-25Pantoprazole sodium25 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION254
71839-122-25Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-122-01EA - Each71839-122e1006291-c0ef-4926-bbc5-19144763fa0e12022-06-06
71839-122-10EA - Each71839-122e383b669-43e6-448a-bd35-b87e3508f48c12022-06-06
71839-122-25EA - Each71839-122773dcc2f-e4ad-47ce-ba53-110af569ac4012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-122PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [BE PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 6 package rows20250315_52d5bc28-66df-43aa-bb1a-8ac4a2a7f693.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN52d5bc28-66df-43aa-bb1a-8ac4a2a7f6934
283669pantoprazole 40 MG InjectionSCD52d5bc28-66df-43aa-bb1a-8ac4a2a7f6934
283669pantoprazole (as sodium) 40 MG InjectionSY52d5bc28-66df-43aa-bb1a-8ac4a2a7f6934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71839-122-01718390122011 VIAL in 1 CARTON (71839-122-01) / 10 mL in 1 VIAL1 vial2022-05-250000-00-00NoNoCurrent
71839-122-107183901221010 CARTON in 1 PACKAGE (71839-122-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL10 carton2022-05-250000-00-00NoNoCurrent
71839-122-257183901222525 CARTON in 1 PACKAGE (71839-122-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL25 carton2022-05-250000-00-00NoNoCurrent