RABEPRAZOLE SODIUM

Product NDC
72189-169
Requested package NDC
72189-169-90
11-digit product format
721890169
Labeler code
72189
Product ID
72189-169_2be9206c-ed86-e301-e063-6294a90a43a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RABEPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208644
Marketing category
ANDA
Marketing start
2021-01-14
Substance
RABEPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-16972189-169-90UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208644-001RABEPRAZOLE 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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208644-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2018-04-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208644-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
RABEPRAZOLE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RABEPRAZOLE SODIUM20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3L36P16U4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854868Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1b7def0-834f-37f5-e053-2a95a90ade1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-169-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE308
72189-169-60RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE608
72189-169-90RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-169-30EA - Each72189-1695e0c6408-3360-49e9-9854-9b1a56b2413f12021-07-15
72189-169-60EA - Each72189-169e6786ff3-7a05-41fd-9b28-ebd1807f864812021-08-05
72189-169-90EA - Each72189-169f58d7dc1-477c-4026-b19a-537065f6d55212021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-169RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]8Current NDC, Legacy NDC, 3 package rows20250119_b1b7def0-834f-37f5-e053-2a95a90ade1f.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 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
Rabeprazole SodiumRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacy9237eaa4-8eec-fb2a-e053-2995a90ab6c02026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP68b7a793-f22b-4609-a640-94fdec703d932026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
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
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb354053c-cb83-79c6-e053-2a95a90afdbe2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
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
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 (package): 72189-169-90
ndc (product): 72189-169
ndc11 (package): 72189016990
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepack9ea2552c-873c-4ab2-84b0-dd54e84e4eee2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644
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
Rabeprazole SodiumRABEPRAZOLE SODIUMA-S Medication Solutions4ded337a-31b8-47c3-b5ab-33a785afb7d82023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208644
application number: ANDA208644

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb1b7def0-834f-37f5-e053-2a95a90ade1f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-169-907218901699090 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-169-90) 2021-01-140000-00-00NoNoCurrent