FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
46708-071
11-digit product format
467080071
Labeler code
46708
Product ID
46708-071_02ee7ed6-217f-4128-bbbb-b9390475a65b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium injection
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA219230
Marketing category
ANDA
Marketing start
2025-03-31
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
46708-071-01PANTOPRAZOLE SODIUM10 mL in 1 VIALPOWDER, FOR SOLUTION101
46708-071-01PANTOPRAZOLE SODIUM1 in 1 CARTONPOWDER, FOR SOLUTION11
46708-071-10PANTOPRAZOLE SODIUM10 mL in 1 VIALPOWDER, FOR SOLUTION101
46708-071-10PANTOPRAZOLE SODIUM10 in 1 CARTONPOWDER, FOR SOLUTION101
46708-071-25PANTOPRAZOLE SODIUM25 in 1 CARTONPOWDER, FOR SOLUTION251
46708-071-25PANTOPRAZOLE SODIUM10 mL in 1 VIALPOWDER, FOR SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-071PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM INJECTION) POWDER, FOR SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 6 package rows20250409_02ee7ed6-217f-4128-bbbb-b9390475a65b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN02ee7ed6-217f-4128-bbbb-b9390475a65b1
283669pantoprazole 40 MG InjectionSCD02ee7ed6-217f-4128-bbbb-b9390475a65b1
283669pantoprazole (as sodium) 40 MG InjectionSY02ee7ed6-217f-4128-bbbb-b9390475a65b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-071-01467080071011 VIAL in 1 CARTON (46708-071-01) / 10 mL in 1 VIAL1 vial2025-03-31NoNoCurrent
46708-071-104670800711010 VIAL in 1 CARTON (46708-071-10) / 10 mL in 1 VIAL10 vial2025-03-31NoNoCurrent
46708-071-254670800712525 VIAL in 1 CARTON (46708-071-25) / 10 mL in 1 VIAL25 vial2025-03-31NoNoCurrent