Application 078964

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORAL20MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078964-001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078964-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078964-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078964-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078964-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078964-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078964-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078964-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078964-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078964-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078964-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078964-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078964-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078964-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078964-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078964-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078964-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078964-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078964-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078964-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078964-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078964-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078964-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078964-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078964-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078964-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078964-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078964-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078964-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078964-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078964-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078964-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078964-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078964-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078964-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078964-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078964-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078964-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078964-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078964-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078964-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078964-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078964-001AB1e64feba35796…

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 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.0e2e00fa-c4c5-4de7-adf9-cd9786b970162026-08-04Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMREMEDYREPACK INC.63e0b7ca-6b2d-42a9-b9d4-4523b8a204252026-07-27Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
Rabeprazole sodiumRABEPRAZOLE SODIUMTorrent Pharmaceuticals Limited04e88b86-e1dd-4c56-8359-45fbcc161f7d2026-07-27Warnings, Adverse reactionsName fallback
brand name: Rabeprazole sodium
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacy9237eaa4-8eec-fb2a-e053-2995a90ab6c02026-06-26Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacyc212c9d5-32d3-3c5f-e053-2a95a90af88b2026-06-02Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack4e8b9858-23a1-4363-b26f-ee6b9ff7ebf92026-05-15Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP68b7a793-f22b-4609-a640-94fdec703d932026-05-01Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbdad0b58-495e-2352-e053-2a95a90a31982026-03-26Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb354053c-cb83-79c6-e053-2a95a90afdbe2026-03-13Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack350c20b0-1879-d4cb-e063-6294a90a37f22026-03-13Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.3b6a25c2-fb61-4c86-9988-c6ffac7939c42026-02-14Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
AciphexRABEPRAZOLE SODIUMWaylis Therapeutics LLC1eb38279-0237-4967-be7a-c53a826c11382026-01-27Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvagen Pharma Limitedb1a12c83-74ab-febc-e053-2a95a90a14412026-01-13Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMChartwell RX, LLCc5c43222-d167-4152-b5c7-84b55920a7ce2025-12-11Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
Rabeprazole sodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.1855ccab-c377-4962-9225-3c5adc62e2bd2025-12-08Warnings, Adverse reactionsName fallback
brand name: Rabeprazole sodium
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ac9266ed-a9b2-4e77-8607-393b5dcdd2b62025-09-17Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.4582d443-f1be-4f94-85da-49aa603f54e42025-09-17Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMPHOENIX RX LLC3a674849-b2f6-5f43-e063-6294a90a9e202025-07-21Warnings, Adverse reactionsName fallback
brand name: Rabeprazole Sodium
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXb1b7def0-834f-37f5-e053-2a95a90ade1f2025-01-17Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC0863f340-4c7e-379a-e063-6394a90a758d2024-12-31Warnings, Adverse reactionsName fallback
brand name: RABEPRAZOLE SODIUM
generic name: RABEPRAZOLE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-802RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMmedsource pharmaceuticalsANDACurrent
50090-1424RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMA-S Medication SolutionsANDACurrent
63187-788RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LPANDACurrent
63187-788RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LPANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68788-6864RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6864RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18490ORIG2013-11-19
9205ORIG2013-11-12