FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM DELAYED-RELEASE

Product NDC
69097-531
11-digit product format
690970531
Labeler code
69097
Product ID
69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium granules
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA217458
Marketing category
ANDA
Marketing start
2025-04-03
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 DELAYED-RELEASE
Brand name suffix
delayed release
Listing expiration
2026-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-531-31PANTOPRAZOLE SODIUM DELAYED-RELEASEdelayed release1 in 1 PACKETSUSPENSION14
69097-531-53PANTOPRAZOLE SODIUM DELAYED-RELEASEdelayed release30 in 1 CARTONSUSPENSION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-531-31EA - Each69097-5312bcc6310-9a39-485c-ab60-32131f2d770212025-06-13
69097-531-53EA - Each69097-531a777b50d-139d-4cda-adc8-c48a0664b84a12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-531PANTOPRAZOLE SODIUM DELAYED-RELEASE DELAYED RELEASE (PANTOPRAZOLE SODIUM GRANULES) SUSPENSION [CIPLA USA INC.]4Current NDC, 2 package rows20250406_195e06db-b76c-4470-b6a5-a3979c25046d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSN195e06db-b76c-4470-b6a5-a3979c25046d4
763306pantoprazole 40 MG Oral GranulesSCD195e06db-b76c-4470-b6a5-a3979c25046d4
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSY195e06db-b76c-4470-b6a5-a3979c25046d4
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSY195e06db-b76c-4470-b6a5-a3979c25046d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-531-31690970531311 in 1 PACKETHistorical
69097-531-536909705315330 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31) 30 packet2025-04-03NoNoHistorical