FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0143-9300
11-digit product format
001439300
Labeler code
0143
Product ID
0143-9300_673b147b-f117-4f86-b22c-e78ea92fb0e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA209463
Marketing category
NDA
Marketing start
2017-09-22
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
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/1

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
0143-9300-01Pantoprazole Sodium1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,18
0143-9300-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9300-01EA - Each0143-9300002a7e38-11dc-401f-a3e3-8016fcd74b9812018-03-08
0143-9300-10EA - Each0143-9300abb7b646-531e-45b7-86f2-2b734d73fc1412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9300PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20231031_1e102c44-232b-4aaf-b457-2a740c47193a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN1e102c44-232b-4aaf-b457-2a740c47193a8
283669pantoprazole 40 MG InjectionSCD1e102c44-232b-4aaf-b457-2a740c47193a8
283669pantoprazole (as sodium) 40 MG InjectionSY1e102c44-232b-4aaf-b457-2a740c47193a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9300-01001439300011 in 1 VIALHistorical
0143-9300-100014393001010 VIAL in 1 CARTON (0143-9300-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9300-01) 10 vial2017-09-220000-00-00NoNoCurrent