Pantoprazole Sodium

Product NDC
68071-2231
Requested package NDC
68071-2231-3
11-digit product format
680712231
Labeler code
68071
Product ID
68071-2231_ac397028-d91c-5089-e053-2a95a90ac0c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090074
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-223168071-2231-3IInactivated by FDA2026-08-03

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 1 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A090074-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19
A090074-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090074-001AB
A090074-002AB

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 · 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 UTC2026-02A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090074-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A090074-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090074-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090074-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090074-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090074-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090074-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090074-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090074-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090074-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090074-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090074-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090074-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090074-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090074-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090074-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090074-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090074-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090074-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090074-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090074-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090074-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090074-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090074-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090074-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090074-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090074-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090074-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090074-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090074-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090074-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090074-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090074-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090074-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090074-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090074-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090074-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090074-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090074-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090074-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090074-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090074-002AB1782e0a99824c…

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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2231-3Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2231PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20200807_ac397028-d91b-5089-e053-2a95a90ac0c9.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6b5ed424-2203-482f-bb85-2c97d9c356f22026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090074
application number: ANDA090074
Pantoprazole SodiumPANTOPRAZOLE SODIUMMajor Pharmaceuticals9c286e5c-2b36-422b-9f74-e8c0abb3f7472026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090074
application number: ANDA090074
Pantoprazole SodiumPANTOPRAZOLE SODIUMTorrent Pharmaceuticals Limited9c983da1-a8e0-479e-8816-5d5668ea242e2026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090074
application number: ANDA090074
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions81696241-17d5-4d35-9e59-8c28469ffd2c2025-03-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090074
application number: ANDA090074
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals, Inc.4fbec80c-b38d-122c-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090074
application number: ANDA090074

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNac397028-d91b-5089-e053-2a95a90ac0c91
314200pantoprazole 40 MG Delayed Release Oral TabletSCDac397028-d91b-5089-e053-2a95a90ac0c91
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYac397028-d91b-5089-e053-2a95a90ac0c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2231-36807122310330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2231-3) 2020-08-060000-00-00NoNoCurrent