PANTOPRAZOLE SODIUM D/R

Product NDC
61919-700
11-digit product format
619190700
Labeler code
61919
Product ID
61919-700_ea4eba83-bc84-6424-e053-2a95a90ab692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM D/R
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090074
Marketing category
ANDA
Marketing start
2019-08-28
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
2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-700IInactivated by FDA2026-08-03
excluded productproduct61919-700IInactivated by FDA2026-08-03
excluded productproduct61919-700IInactivated by FDA2026-08-03
excluded packagepackage61919-70061919-700-90IInactivated by FDA2026-08-03
excluded packagepackage61919-70061919-700-30IInactivated by FDA2026-08-03
excluded packagepackage61919-70061919-700-40IInactivated 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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-700-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-700-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-700-40IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-700-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-700-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-700-40IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-700-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-700-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-700-40IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-700-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-700-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-700-40IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-700-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-700-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-700-40IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-700-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-700-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-700-40IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-700-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-700-40UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-700-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-700-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-700-40UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-700-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-700-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-700-40UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-700-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-700-302025-01-30C16284748780-12cef2736-74dc-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R
61919-700-402025-01-30C16284748780-12cef2736-7bf6-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R
61919-700-902025-01-30C16284748780-12cef2736-7a87-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-700-30PANTOPRAZOLE SODIUM D/R30 in 1 BOTTLETABLET, DELAYED RELEASE302
61919-700-40PANTOPRAZOLE SODIUM D/R40 in 1 BOTTLETABLET, DELAYED RELEASE402
61919-700-90PANTOPRAZOLE SODIUM D/R90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-700-30EA - Each61919-700573db7ea-44fc-4115-84f5-1db64533780a12019-09-05
61919-700-40EA - Each61919-700304917b2-0454-4dee-a67a-ec97e99a310412019-09-05
61919-700-90EA - Each61919-700e7c5627f-8c28-47f4-ab8e-c00968ec538612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT_RX]2Legacy NDC, 1 package rows20221007_913221df-021c-e511-e053-2995a90a4948.zip
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT_RX]2Legacy NDC, 1 package rows20221007_914372d5-3500-4e91-e053-2a95a90a4855.zip
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20190119_7cc5510a-8777-3878-e053-2a91aa0a5d32.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 TabletPSN913221df-021c-e511-e053-2995a90a49482
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG Delayed Release Oral TabletSCD913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG Delayed Release Oral TabletSCD914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7cc5510a-8777-3878-e053-2a91aa0a5d321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-700-306191907003030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-30) 2019-08-290000-00-00NoNoCurrent
61919-700-406191907004040 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-40) 2019-08-280000-00-00NoNoCurrent
61919-700-906191907009090 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-90) 2018-12-110000-00-00NoNoCurrent