FDA.reportPublic FDA data

pantoprazole sodium

Product NDC
70010-191
11-digit product format
700100191
Labeler code
70010
Product ID
70010-191_4ec4732c-38ba-bcc3-e063-6294a90a823c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA217282
Marketing category
ANDA
Marketing start
2024-04-12
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
Rxcui251872, 314200

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
70010-191-09pantoprazole sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903
70010-191-10pantoprazole sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-191-09EA - Each70010-191bab6222e-784a-4d02-a1e0-5ef3bde2588912024-09-09
70010-191-10EA - Each70010-191506c3394-c8fd-4807-96dc-01a7c0a6775b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-191PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [GRANULES PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240413_8f2fb647-15bc-41cb-84a4-02e956e614fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN8f2fb647-15bc-41cb-84a4-02e956e614fc3
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8f2fb647-15bc-41cb-84a4-02e956e614fc3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD8f2fb647-15bc-41cb-84a4-02e956e614fc3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8f2fb647-15bc-41cb-84a4-02e956e614fc3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY8f2fb647-15bc-41cb-84a4-02e956e614fc3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY8f2fb647-15bc-41cb-84a4-02e956e614fc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-191-097001001910990 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-191-09) 2024-04-12NoNoCurrent
70010-191-10700100191101000 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-191-10) 2024-04-12NoNoCurrent