FDA.reportPublic FDA data

Pantoprazole sodium

Product NDC
27241-256
11-digit product format
272410256
Labeler code
27241
Product ID
27241-256_d0fe5d1b-fb0c-4c7b-af8b-cda49f2c8f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA217416
Marketing category
ANDA
Marketing start
2023-02-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui763306

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
27241-256-11Pantoprazole sodium1 in 1 PACKETFOR SUSPENSION15
27241-256-38Pantoprazole sodium30 in 1 CARTONFOR SUSPENSION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-256-11EA - Each27241-256b20624e2-fc86-41fb-a787-4223388ea2ed12023-04-07
27241-256-38EA - Each27241-25627743fd3-a8c3-4439-aa6c-0773c28dec3f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-256PANTOPRAZOLE SODIUM FOR SUSPENSION [AJANTA PHARMA USA INC.]4Current NDC, 2 package rows20240711_90963a38-f629-45a4-bddd-9e13a55fe0f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN90963a38-f629-45a4-bddd-9e13a55fe0f75
763306pantoprazole 40 MG Oral GranulesSCD90963a38-f629-45a4-bddd-9e13a55fe0f75
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY90963a38-f629-45a4-bddd-9e13a55fe0f75
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY90963a38-f629-45a4-bddd-9e13a55fe0f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-256-11272410256111 FOR SUSPENSION in 1 PACKET (27241-256-11) 1 for suspension2023-02-09NoNoCurrent
27241-256-382724102563830 FOR SUSPENSION in 1 CARTON (27241-256-38) 30 for suspension2023-02-09NoNoCurrent