Pantoprazole Sodium

Product NDC
0615-7998
11-digit product format
006157998
Labeler code
0615
Product ID
0615-7998_67b69930-947c-40c4-ae40-f3d285ace0d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-19
Marketing end
2021-04-30
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
0000-00-00
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7998DDiscontinued by firm2026-08-03
excluded packagepackage0615-79980615-7998-05DDiscontinued by firm2026-08-03
excluded packagepackage0615-79980615-7998-07DDiscontinued by firm2026-08-03
excluded packagepackage0615-79980615-7998-14DDiscontinued by firm2026-08-03
excluded packagepackage0615-79980615-7998-30DDiscontinued by firm2026-08-03
excluded packagepackage0615-79980615-7998-39DDiscontinued by firm2026-08-03

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 2 · 72 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 packagepackage0615-7998-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7998-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7998-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7998-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7998-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7998-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7998-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7998-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7998-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7998-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7998-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7998-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7998-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7998-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7998-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7998-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7998-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7998-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7998-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7998-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7998-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7998-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7998-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7998-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7998-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7998-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7998-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7998-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7998-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7998-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7998-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7998-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7998-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7998-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7998-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7998-39ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7998-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7998-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7998-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7998-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7998-390efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7998-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7998-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7998-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7998-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7998-39ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7998-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7998-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7998-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7998-05ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077056-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02
A077056-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077056-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077056-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077056-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077056-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077056-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077056-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077056-002AB1ea99ee380514…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7998-050061579980515 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7998-05) 2016-04-052021-04-30NoNoCurrent
0615-7998-07006157998077 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7998-07) 2018-09-282021-04-30NoNoCurrent
0615-7998-140061579981414 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7998-14) 2018-09-282021-04-30NoNoCurrent
0615-7998-30006157998306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7998-30) > 5 TABLET, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2016-04-052021-04-30NoNoCurrent
0615-7998-390061579983930 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7998-39) 2016-04-052021-04-30NoNoCurrent