FDA.reportPublic FDA data

NDC 70095-024-01 - Pantoprazole sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70095-024
Requested NDC
70095-024-01
Package NDCs from labels
70095-024-01, 70095-024-02, 70095-024-03
Manufacturer
Sun Pharmaceutical Industries Limited | Gland Pharma Limited
Effective date
2025-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PANTOPRAZOLE - Sun Pharmaceutical Industries Limited | Gland Pharma LimitedSun Pharmaceutical Industries Limited | Gland Pharma Limited2025-04-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70095-024-01Pantoprazole sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,104
70095-024-02Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70095-024-02Pantoprazole sodium10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,104
70095-024-03Pantoprazole sodium25 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,254
70095-024-03Pantoprazole sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-024PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED]4Current NDC, 5 package rows20250406_eb3f58d4-0c69-4377-be45-c36099c98d33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70095-024-01EA - Each70095-0242ed3b743-c98b-4188-bd77-39799db3875d12023-07-06
70095-024-02EA - Each70095-024a764b9eb-0f5e-42bf-bff9-eca33ea55f4812023-06-06
70095-024-03EA - Each70095-0247ad39138-1b02-42d1-880c-96ee7da1476712023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PantoprazolePANTOPRAZOLESt. Mary's Medical Park Pharmacyed264262-21bb-1bae-e053-2995a90a8a5e2026-06-17Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack03dea010-4bae-43ab-893e-9bbddb58062d2026-06-05Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC5331f534-4724-52e8-e063-6394a90aa5482026-06-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC52bbab54-9f11-77bc-e063-6394a90ab4492026-05-26Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMGland Pharma Limitedc1ad8f91-3783-4139-8154-e461a53809c12026-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA204400
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack9a1159d3-b9fa-4026-962c-d3001002e6102026-05-19Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Protonix Delayed-ReleasePANTOPRAZOLE SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.08098cb2-c048-4640-f387-6beec4a389362026-05-18Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepackfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a2026-05-13Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Inc0e200326-8885-18d0-e063-6294a90aad2f2026-05-11Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals,Inc.51033ddc-a11a-80fa-e063-6394a90ac54c2026-05-04Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthstar Rx LLC7e0c5dac-6832-4692-b012-ca59d5e889872026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMSafecor Health LLC5e1cbf26-d379-4315-8732-3939968f32c02026-04-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
pantoprazole sodiumPANTOPRAZOLE SODIUMGranules Pharmaceuticals Inc.8f2fb647-15bc-41cb-84a4-02e956e614fc2026-04-06Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Protonix I.V.PANTOPRAZOLE SODIUMCardinal Health 107, LLC50802e19-72d3-4130-8d14-eb94361b38e72026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUM DRDirect_Rx0515ceaa-7d17-c92f-e063-6294a90a044e2026-03-05Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEAmneal Pharmaceuticals LLCf3ded82a-cf0d-4844-944a-75f9f9215ff02026-03-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6b5ed424-2203-482f-bb85-2c97d9c356f22026-02-27Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEPD-Rx Pharmaceuticals, Inc.c1f37929-a981-4ace-95e6-ae6795a797b32026-02-25Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMajor Pharmaceuticals9c286e5c-2b36-422b-9f74-e8c0abb3f7472026-02-12Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAurobindo Pharma Limited7418f358-f536-4de6-adf0-562b4373f2e32026-02-06Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.