PANTOPRAZOLE SODIUM

Product NDC
55700-850
Requested package NDC
55700-850-90
11-digit product format
557000850
Labeler code
55700
Product ID
55700-850_ce8cb1a4-2ced-47b0-b0a6-0d2f103b3f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2020-03-20
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-85055700-850-90DDiscontinued by firm2026-08-17

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 · 9 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202882-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10
A202882-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202882-001AB
A202882-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202882-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202882-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202882-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202882-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202882-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202882-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202882-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202882-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202882-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202882-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202882-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202882-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202882-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202882-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202882-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-850-30EA - Each55700-850037df77b-f463-4e28-bb2b-f0adbe8cb6cf12020-04-20
55700-850-60EA - Each55700-8508923e241-2e8e-4ae7-a125-eb4dba9001fe12020-04-20
55700-850-90EA - Each55700-85019a6ac33-8d41-4420-91bc-d719428e8ffb12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-850PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [QUALITY CARE PRODUCTS, LLC]11Legacy NDC20241220_65098903-ccb5-4daf-ab1b-d9823fc73066.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park Pharmacye1aa55ec-5e0e-3a58-e053-2a95a90abe4f2026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepackfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUM DRDirect_Rx0515ceaa-7d17-c92f-e063-6294a90a044e2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEPD-Rx Pharmaceuticals, Inc.c1f37929-a981-4ace-95e6-ae6795a797b32026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.9daa1483-5a36-44db-9e0d-904d100da2622026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLC643eb498-d916-4fb7-9281-32895575ab362026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENorthwind Health Company, LLCda67e1c0-9947-957d-e053-2a95a90ad96d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEQPharma Incb4a94a37-47c1-4dd9-9e4d-5b4a03480aa62025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEDIRECT RXa7e7c1ab-3e75-1ff8-e053-2995a90a75392025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCc89a5396-1d94-c7fa-e053-2995a90a90632024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbd4759ac-46b5-6903-e053-2a95a90a63192024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf5c9e3c6-d4b0-0ebe-e053-2995a90abe552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-850-905570008509090 TABLET, DELAYED RELEASE in 1 BOTTLE (55700-850-90) 2020-03-200000-00-00NoNoCurrent