FDA.report

Pantoprazole Sodium

Product NDC
65862-560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202038
Marketing category
ANDA
Substance
PANTOPRAZOLE SODIUM
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
65862-560-05500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-05) 20251204NoHistorical
65862-560-1010 BLISTER PACK in 1 CARTON (65862-560-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK20120928NoHistorical
65862-560-9090 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-90) 20120928NoHistorical
65862-560-991000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-99) 20120928NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
52bbab54-9f11-77bc-e063-6394a90ab449These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Coupler LLC2026-05-26HUMAN PRESCRIPTION DRUG LABEL1
9a1159d3-b9fa-4026-962c-d3001002e610These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Bryant Ranch Prepack2026-05-19HUMAN PRESCRIPTION DRUG LABEL8
0e200326-8885-18d0-e063-6294a90aad2fThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000QPharma Inc | Northwind Health Company, LLC2026-05-11HUMAN PRESCRIPTION DRUG LABEL3
f38a6df2-1dd4-48bf-9ec4-1113ce492e78These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000REMEDYREPACK INC.2026-05-04HUMAN PRESCRIPTION DRUG LABEL23
f313159c-115a-4cf6-b32e-9ddc833fd51cThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000REMEDYREPACK INC.2026-03-17HUMAN PRESCRIPTION DRUG LABEL19
7418f358-f536-4de6-adf0-562b4373f2e3These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Aurobindo Pharma Limited2026-02-06Human Prescription Drug Label24
de419aa0-caa9-40fb-bc6d-e341c94273c7These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Major Pharmaceuticals2026-01-08HUMAN PRESCRIPTION DRUG LABEL6
d9deb251-96d3-5f96-e053-2a95a90a0792These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Northwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL4
8aac1642-6cb0-6ad2-e053-2a95a90a4cbdThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000NuCare Pharmaceuticals,Inc.2025-01-31HUMAN PRESCRIPTION DRUG LABEL5
de419aa0-caa9-40fb-bc6d-e341c94273c7These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Major Pharmaceuticals2024-10-07HUMAN PRESCRIPTION DRUG LABEL4
5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000American Health Packaging2024-09-20HUMAN PRESCRIPTION DRUG LABEL2
b2d26299-a48e-7b23-e053-2a95a90ae9e6Pantoprazole DR 40mgRedPharm Drug2024-07-25HUMAN PRESCRIPTION DRUG LABEL9
88f408cf-1b3e-4d7a-e053-2a95a90a369fThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000NuCare Pharmaceuticals,Inc.2024-06-14HUMAN PRESCRIPTION DRUG LABEL3
138b30cb-6b28-450e-9e7a-42576cc76545These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-05-01HUMAN PRESCRIPTION DRUG LABEL1
485212d4-caee-4a55-8299-87a28d6bd8f0These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000A-S Medication Solutions2024-04-29Human Prescription Drug Label5
f1eb666a-120d-47fd-8c9f-73cef839294aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000A-S Medication Solutions2023-07-31Human Prescription Drug Label7
a8dd30a8-8c63-4e57-95bd-1363a6a3a9b7These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Aphena Pharma Solutions - Tennessee, LLC2019-02-08Human Prescription Drug Label1
58b379ed-8603-4c2d-e053-2991aa0a8919These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use 536 Initial U.S. approval: 2000Contract Pharmacy Services-PA | Coupler Enterprises2018-12-19HUMAN PRESCRIPTION DRUG LABEL3