Rabeprazole Sodium

Product NDC
62175-302
Requested package NDC
62175-302-43
11-digit product format
621750302
Labeler code
62175
Product ID
62175-302_dde0e5ce-043b-4ada-aa94-eab41e41bc17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA090678
Marketing category
ANDA
Marketing start
2013-11-08
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

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
A090678-001RABEPRAZOLE 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
A090678-001AB

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 UTC2026-02A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090678-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08cb3db0bc1861…

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 UTC2026-02A090678-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090678-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090678-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090678-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090678-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090678-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090678-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090678-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090678-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090678-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090678-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090678-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090678-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090678-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090678-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090678-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090678-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090678-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090678-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090678-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090678-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090678-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090678-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090678-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090678-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090678-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090678-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090678-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090678-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090678-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090678-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090678-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090678-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090678-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090678-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090678-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090678-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090678-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090678-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090678-001AB1cb3db0bc1861…

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
7f7d68f0-972b-4315-b712-0bb8a84c85ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-302-32Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3027
62175-302-41Rabeprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50027
62175-302-42Rabeprazole Sodium250 in 1 BOTTLETABLET, DELAYED RELEASE25027
62175-302-43Rabeprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100027
62175-302-46Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-302-32EA - Each62175-302b97747d2-da70-4001-baf5-081b8392559712013-12-02
62175-302-43EA - Each62175-302ed9bfcf7-20aa-45a4-afff-c96ae602ae6712014-04-03
62175-302-46EA - Each62175-30271f9b1c3-1489-48ad-903f-279a9b33c2cd12013-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-302RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [LANNETT COMPANY, INC.]27Current NDC, Legacy NDC, 5 package rows20230819_7f7d68f0-972b-4315-b712-0bb8a84c85cc.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole SodiumRABEPRAZOLE SODIUMChartwell RX, LLCc5c43222-d167-4152-b5c7-84b55920a7ce2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090678
application number: ANDA090678
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP14412af6-e99c-4264-bc34-28a6f139f2522024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090678
application number: ANDA090678
Rabeprazole SodiumRABEPRAZOLE SODIUMGolden State Medical Supply, Inc.87231460-8b1e-b995-e053-2a91aa0a6c432024-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090678
application number: ANDA090678
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepacke6350638-99b0-474d-be75-ae2a3e1af2cf2023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090678
application number: ANDA090678
Rabeprazole SodiumRABEPRAZOLE SODIUMLannett Company, Inc.7f7d68f0-972b-4315-b712-0bb8a84c85cc2023-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090678
application number: ANDA090678
ndc (package): 62175-302-43
ndc (product): 62175-302
ndc11 (package): 62175030243

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN7f7d68f0-972b-4315-b712-0bb8a84c85cc27
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD7f7d68f0-972b-4315-b712-0bb8a84c85cc27
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNe6350638-99b0-474d-be75-ae2a3e1af2cf11
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDe6350638-99b0-474d-be75-ae2a3e1af2cf11
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN6b34e763-d874-46a4-98ac-261fdec62a879
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN87231460-8b1e-b995-e053-2a91aa0a6c439
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD6b34e763-d874-46a4-98ac-261fdec62a879
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD87231460-8b1e-b995-e053-2a91aa0a6c439
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN14412af6-e99c-4264-bc34-28a6f139f2525
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD14412af6-e99c-4264-bc34-28a6f139f2525
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN8699d125-0928-458f-a232-9864497c73cb4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD8699d125-0928-458f-a232-9864497c73cb4
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9fe50049-72a7-0284-e053-2a95a90a93b23
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9fe50049-72a7-0284-e053-2a95a90a93b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-302-43621750302431000 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-302-43) 2013-11-080000-00-00NoNoCurrent