Pantoprazole Sodium

Product NDC
68071-3140
11-digit product format
680713140
Labeler code
68071
Product ID
68071-3140_49afdf89-0b99-71da-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-3140DDiscontinued by firm2026-10-05
excluded packagepackage68071-314068071-3140-3DDiscontinued by firm2026-10-05
excluded packagepackage68071-314068071-3140-6DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-3140-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-3140-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-3140-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-3140-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-3140-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-3140-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-3140-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-3140-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-3140-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-3140-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-3140-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-3140-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3140-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3140-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3140-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3140-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3140-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3140-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-3140-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-3140-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-3140-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-3140-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3140-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3140-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078281-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20
A078281-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078281-001AB
A078281-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2084e616aacf4f…
2026-09-14 22:38:342026-08A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2084e616aacf4f…
2026-08-18 06:07:402026-07A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078281-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078281-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A078281-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078281-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078281-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078281-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078281-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078281-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078281-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078281-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078281-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078281-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078281-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078281-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078281-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078281-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMAvPAKdcac4022-fea1-67c5-3331-fefcc3c440d82026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC410d5577-e50a-44f3-aaa8-fbf391a0c2612025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMChartwell RX, LLC42a969c3-1144-4151-9cf3-3e9bace6a3802025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMAvPAKb9fa8381-b75e-b1cd-e053-2a95a90a98832025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMPD-Rx Pharmaceuticals, Inc.b422c5eb-9a6d-4f8c-863d-ca515ec780c22025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMAphena Pharma Solutions - Tennessee, LLCc9bc288b-e84c-4e31-a769-c87a592260862025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMGolden State Medical Supply, Inc.d6aae78e-308b-7072-e053-2a95a90aaa102024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMLannett Company, Inc.e7705bf6-e473-4b9c-bb5d-57e26ffe7b972023-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMProficient Rx LPa03aa46f-9eb5-4cf4-addf-745d94af82612022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281