FDA.reportPublic FDA data

Pantoprazole sodium

Product NDC
70095-024
11-digit product format
700950024
Labeler code
70095
Product ID
70095-024_b423abbc-01e1-4d07-9c89-a7398c898d2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries Limited
Application
ANDA204400
Marketing category
ANDA
Marketing start
2023-04-03
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
70095-024-01Pantoprazole sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,104
70095-024-02Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70095-024-02Pantoprazole sodium10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,104
70095-024-03Pantoprazole sodium25 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,254
70095-024-03Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70095-024-01EA - Each70095-0242ed3b743-c98b-4188-bd77-39799db3875d12023-07-06
70095-024-02EA - Each70095-024a764b9eb-0f5e-42bf-bff9-eca33ea55f4812023-06-06
70095-024-03EA - Each70095-0247ad39138-1b02-42d1-880c-96ee7da1476712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-024PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED]4Current NDC, 5 package rows20250406_eb3f58d4-0c69-4377-be45-c36099c98d33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNeb3f58d4-0c69-4377-be45-c36099c98d334
283669pantoprazole 40 MG InjectionSCDeb3f58d4-0c69-4377-be45-c36099c98d334
283669pantoprazole (as sodium) 40 MG InjectionSYeb3f58d4-0c69-4377-be45-c36099c98d334

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-024-017009500240110 mL in 1 VIAL10 mlHistorical
70095-024-027009500240210 CARTON in 1 PACKAGE (70095-024-02) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) 10 carton2023-04-03NoNoCurrent
70095-024-037009500240325 CARTON in 1 PACKAGE (70095-024-03) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01) 25 carton2023-04-03NoNoCurrent