Pantoprazole Sodium

Product NDC
55700-318
Requested package NDC
55700-318-60
11-digit product format
557000318
Labeler code
55700
Product ID
55700-318_6f9a6a4b-284f-4acc-81d5-d6cd9bcd9472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-01-19
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
2022-12-31
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 packagepackage55700-31855700-318-60DDiscontinued 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 1 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A090970-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19
A090970-002PANTOPRAZOLE 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
A090970-001AB
A090970-002AB

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 UTC2026-02A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A090970-002PANTOPRAZOLE 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 UTC2026-02A090970-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090970-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090970-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090970-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090970-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090970-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090970-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090970-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090970-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090970-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090970-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090970-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090970-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090970-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090970-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090970-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090970-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090970-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55700-318-302025-01-08These 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, USP, for oral use Initial U.S. Approval: 2000
55700-318-602025-01-08These 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, USP, for oral use Initial U.S. Approval: 2000
55700-318-902025-01-08These 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, USP, for oral use Initial U.S. Approval: 2000
55700-318-302023-01-30These 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, USP, for oral use Initial U.S. Approval: 2000
55700-318-602023-01-30These 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, USP, for oral use Initial U.S. Approval: 2000
55700-318-902023-01-30These 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, USP, for oral use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-318-30EA - Each55700-3180888a6c0-cd72-4d88-bce7-006ced971b7412016-02-04
55700-318-60EA - Each55700-318d62ba920-0bf4-4d5c-ab20-09909b0c849112016-02-04
55700-318-90EA - Each55700-318e61ee99a-09d0-4798-9e12-e0f9f5512d5412017-09-11

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMSafecor Health LLC5e1cbf26-d379-4315-8732-3939968f32c02026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Incfbd035d0-529c-6033-e053-6294a90abf072025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Institutional Inc.a9b0d279-118b-4372-bd51-d4bad9c1cfca2025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd27e1fdd-e23f-0d60-e053-2a95a90a90872024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs6faf465b-c3a3-4ae7-9e16-1ba758f6962a2024-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Pharmaceuticals Inc.56ad5b97-8e5f-48a5-b2ba-a5484b43d0182023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-318-605570003186060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-318-60) 2011-01-190000-00-00NoNoCurrent