Pantoprazole Sodium

Product NDC
60760-639
11-digit product format
607600639
Labeler code
60760
Product ID
60760-639_e39f41ed-0903-9f0e-e053-2995a90ab36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA202038
Marketing category
ANDA
Marketing start
2022-06-22
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
20 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60760-639DDiscontinued by firm2026-08-03
excluded packagepackage60760-63960760-639-60DDiscontinued by firm2026-08-03

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
A202038-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28
A202038-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202038-001AB
A202038-002AB

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 UTC2026-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…

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 UTC2026-02A202038-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-639-60EA - Each60760-63931916fba-80b1-407f-b319-c25464ee611012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-639PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [ST MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20220714_e39f41ed-0902-9f0e-e053-2995a90ab36a.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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack03dea010-4bae-43ab-893e-9bbddb58062d2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC5331f534-4724-52e8-e063-6394a90aa5482026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC52bbab54-9f11-77bc-e063-6394a90ab4492026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack9a1159d3-b9fa-4026-962c-d3001002e6102026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Inc0e200326-8885-18d0-e063-6294a90aad2f2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMAurobindo Pharma Limited7418f358-f536-4de6-adf0-562b4373f2e32026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthStar Rx LLC6637d90b-b268-4a5f-ab5b-885f2d5f0d4b2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBurel Pharmaceuticals, LLC3cc5197e-6b39-4415-b963-d4bbeecd79532026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6229247e-ee15-466e-a8ac-adcd646b738d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMMajor Pharmaceuticalsde419aa0-caa9-40fb-bc6d-e341c94273c72026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCf2a1af50-a051-3e55-e053-2a95a90a91842026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCd9deb251-96d3-5f96-e053-2a95a90a07922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.8aac1642-6cb0-6ad2-e053-2a95a90a4cbd2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMQuality Care Products, LLCa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-639-606076006396060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-639-60) 2022-06-220000-00-00NoNoCurrent