Rabeprazole Sodium

Product NDC
65162-724
11-digit product format
651620724
Labeler code
65162
Product ID
65162-724_f02b0373-dbac-4842-bf97-3352b8c74089
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204179
Marketing category
ANDA
Marketing start
2015-10-01
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 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
A204179-001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204179-001AB

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 06:07:402026-07A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204179-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-07-31e64feba35796…

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 06:07:402026-07A204179-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204179-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204179-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204179-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204179-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204179-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204179-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204179-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204179-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204179-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204179-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204179-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204179-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204179-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204179-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204179-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204179-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204179-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204179-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204179-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204179-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204179-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204179-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204179-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204179-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204179-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204179-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204179-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204179-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204179-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204179-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204179-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204179-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204179-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204179-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204179-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204179-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204179-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204179-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204179-001AB1e64feba35796…

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
951caefe-6e18-48ff-9567-beb545b09c25Available 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
65162-724-03Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3024
65162-724-09Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9024
65162-724-11Rabeprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100024
65162-724-50Rabeprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-724-03EA - Each65162-7247cb75ec9-d335-44cd-b8bd-416a99361d5f12015-12-02
65162-724-09EA - Each65162-724cbbdce9d-bc1a-4ded-baaa-41d097a85dcc12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
CROSPOVIDONE (12 MPA.S AT 5%)INACTIVE INGREDIENT40UAA97IT9RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ARABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SHELLACINACTIVE INGREDIENT46N107B71ORABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1URABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-724RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]24Current NDC, Legacy NDC, 4 package rows20241031_951caefe-6e18-48ff-9567-beb545b09c25.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole SodiumRABEPRAZOLEAmneal Pharmaceuticals LLC951caefe-6e18-48ff-9567-beb545b09c252023-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204179
application number: ANDA204179
ndc (product): 65162-724

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN951caefe-6e18-48ff-9567-beb545b09c2524
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD951caefe-6e18-48ff-9567-beb545b09c2524
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0744d4db-a259-47db-8c6c-d671b4469e5b3
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0744d4db-a259-47db-8c6c-d671b4469e5b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-724-036516207240330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-03) 2015-10-010000-00-00NoNoCurrent
65162-724-096516207240990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-09) 2015-10-010000-00-00NoNoCurrent
65162-724-11651620724111000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-11) 2015-10-010000-00-00NoNoCurrent
65162-724-5065162072450500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-50) 2015-10-010000-00-00NoNoCurrent