Rabeprazole Sodium

Product NDC
65862-721
Requested package NDC
65862-721-59
11-digit product format
658620721
Labeler code
65862
Product ID
65862-721_3a12547f-7c57-44f8-a6bb-d3287701033f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-72165862-721-59UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-721-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE308
65862-721-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-721-30EA - Each65862-7216064ff2e-b4e5-4ea7-aaac-f7c922e32ce812019-03-12
65862-721-90EA - Each65862-7215ea90938-aa92-4722-8cda-530545ff2e1912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-721RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20240301_d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89.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
Rabeprazole SodiumRABEPRAZOLE SODIUMAurobindo Pharma Limitedd11c3211-b4d4-4893-8c1c-b8fb6d0a0b892024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205761
application number: ANDA205761
ndc (product): 65862-721
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 TabletPSNb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNd11c3211-b4d4-4893-8c1c-b8fb6d0a0b898
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDd11c3211-b4d4-4893-8c1c-b8fb6d0a0b898
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN12eaf996-db61-41d6-82e1-fa61964356031
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD12eaf996-db61-41d6-82e1-fa61964356031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-721-59658620721595000 TABLET, DELAYED RELEASE in 1 BAG (65862-721-59)17-FEB-17Current