FDA.reportPublic FDA data

pantoprazole sodium

Product NDC
31722-204
11-digit product format
317220204
Labeler code
31722
Product ID
31722-204_358ef102-b287-cdc7-e063-6394a90aa4a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA213778
Marketing category
ANDA
Marketing start
2022-05-18
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
31722-204-10pantoprazole sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104
31722-204-31pantoprazole sodium1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION14
31722-204-32pantoprazole sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-204-10EA - Each31722-204e3ad21be-5e18-49f8-857b-d24b40b0b57d12023-04-07
31722-204-31EA - Each31722-204fa8a308a-a37b-4841-9fc1-4fec0026316512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-204PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20250522_1bb94d3c-8bc3-4193-9dd8-e9a22066707c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN1bb94d3c-8bc3-4193-9dd8-e9a22066707c4
283669pantoprazole 40 MG InjectionSCD1bb94d3c-8bc3-4193-9dd8-e9a22066707c4
283669pantoprazole (as sodium) 40 MG InjectionSY1bb94d3c-8bc3-4193-9dd8-e9a22066707c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-204-103172202041010 VIAL, SINGLE-DOSE in 1 CARTON (31722-204-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (31722-204-31) 2022-05-180000-00-00NoNoCurrent
31722-204-31317220204311 in 1 VIAL, SINGLE-DOSEHistorical
31722-204-323172202043225 VIAL, SINGLE-DOSE in 1 CARTON (31722-204-32) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (31722-204-31) 2022-05-180000-00-00NoNoCurrent