Application 208644

Type
ANDA
Sponsor
ALKEM LABS 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
A208644-001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208644-001AB

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 06:07:402026-07A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-243f01610625f2…
2019-09-15 20:21 UTC2019-09A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24e64feba35796…

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 06:07:402026-07A208644-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208644-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208644-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208644-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208644-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208644-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208644-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208644-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208644-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208644-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208644-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208644-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208644-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208644-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208644-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208644-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208644-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208644-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208644-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208644-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208644-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208644-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208644-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208644-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208644-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208644-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208644-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208644-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208644-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208644-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208644-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208644-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208644-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208644-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208644-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208644-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208644-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208644-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208644-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208644-001AB1e64feba35796…

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole SodiumRABEPRAZOLE SODIUMREMEDYREPACK INC.63e0b7ca-6b2d-42a9-b9d4-4523b8a204252026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 70518-2590
Rabeprazole SodiumRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacy9237eaa4-8eec-fb2a-e053-2995a90ab6c02026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 60760-560
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP68b7a793-f22b-4609-a640-94fdec703d932026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 71205-292
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbdad0b58-495e-2352-e053-2a95a90a31982026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 80425-0134
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb354053c-cb83-79c6-e053-2a95a90afdbe2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 80425-0094
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.3b6a25c2-fb61-4c86-9988-c6ffac7939c42026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ac9266ed-a9b2-4e77-8607-393b5dcdd2b62025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 68788-7459
Rabeprazole SodiumRABEPRAZOLE SODIUMPHOENIX RX LLC3a674849-b2f6-5f43-e063-6294a90a9e202025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXb1b7def0-834f-37f5-e053-2a95a90ade1f2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 72189-169
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepack9ea2552c-873c-4ab2-84b0-dd54e84e4eee2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 71335-1100
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepack8d8c1a72-b4c4-4699-b9c3-3a39a9df44f22024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
Rabeprazole SodiumRABEPRAZOLE SODIUMAscend Laboratories, LLC45092108-7c4a-48f9-8222-ca8612e821892023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 67877-443
Rabeprazole SodiumRABEPRAZOLE SODIUMA-S Medication Solutions4ded337a-31b8-47c3-b5ab-33a785afb7d82023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
ndc (product): 50090-4751

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-123Rabeprazole SodiumRabeprazole SodiumMedsource PharmaceuticalsANDACurrent
50090-4751Rabeprazole SodiumRabeprazole SodiumA-S Medication SolutionsANDACurrent
50090-4751Rabeprazole SodiumRabeprazole SodiumA-S Medication SolutionsANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
60760-560Rabeprazole SodiumRabeprazole SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-560Rabeprazole SodiumRabeprazole SodiumSt. Mary's Medical Park PharmacyANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70934-403Rabeprazole SodiumRabeprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-403Rabeprazole SodiumRabeprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
80425-0094AciphexRabeprazole Sodium 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134AciphexRabeprazole 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent