Rabeprazole Sodium

Product NDC
71335-1558
Requested package NDC
71335-1558-5
11-digit product format
713351558
Labeler code
71335
Product ID
71335-1558_cd70a996-b785-4b4b-b0d5-868c7aaf323e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205761
Marketing category
ANDA
Marketing start
2017-02-17
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 · 2 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
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-155871335-1558-5IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-155871335-1558-5IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A205761-001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205761-001AB

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 06:07:402026-07A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205761-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2017-02-17e64feba35796…

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 06:07:402026-07A205761-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205761-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205761-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205761-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205761-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205761-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205761-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205761-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205761-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205761-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205761-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205761-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205761-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205761-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205761-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205761-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205761-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205761-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205761-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205761-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205761-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205761-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205761-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205761-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205761-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205761-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205761-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205761-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205761-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205761-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205761-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205761-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205761-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205761-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205761-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205761-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205761-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205761-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205761-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205761-001AB1e64feba35796…

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
b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bfAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1558-22024-05-20These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-32024-05-20These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-42024-05-20These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-52024-05-20These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-62024-05-20These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-22024-01-30These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-32024-01-30These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-42024-01-30These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-52024-01-30These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
71335-1558-62024-01-30These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1558-2Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE904
71335-1558-3Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
71335-1558-4Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE604
71335-1558-5Rabeprazole Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE284
71335-1558-6Rabeprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1558-3EA - Each71335-155815958c1e-2982-4078-8e88-ea124706d79012025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1558RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20240522_b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXb1b7def0-834f-37f5-e053-2a95a90ade1f2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205761
application number: ANDA205761
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepackb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf2024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205761
application number: ANDA205761
ndc (package): 71335-1558-5
ndc (product): 71335-1558
ndc11 (package): 71335155805
Rabeprazole SodiumRABEPRAZOLE SODIUMAurobindo Pharma Limitedd11c3211-b4d4-4893-8c1c-b8fb6d0a0b892024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205761
application number: ANDA205761
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.12eaf996-db61-41d6-82e1-fa61964356032020-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205761
application number: ANDA205761

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1558-57133515580528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-5) 2022-05-020000-00-00NoNoCurrent