FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
72888-059
11-digit product format
728880059
Labeler code
72888
Product ID
72888-059_4844a51a-513a-8b72-e063-6294a90ab996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA204237
Marketing category
ANDA
Marketing start
2017-06-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204237-001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204237-001AB

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A204237-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-11-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204237-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-11-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204237-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-11-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204237-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2015-11-18a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10A204237-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204237-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204237-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204237-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
RABEPRAZOLE SODIUM
Listing expiration
2027-12-31

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
b1a12c83-74ab-febc-e053-2a95a90a1441Available 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
72888-059-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE309
72888-059-90RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-059-30EA - Each72888-059688577ee-d6f0-4be4-aa20-48e7fc584aaa12021-01-08
72888-059-90EA - Each72888-059992fe7c7-b818-4acf-aeba-0b2ed01d373812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-059RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ADVAGEN PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20210513_b1a12c83-74ab-febc-e053-2a95a90a1441.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.4582d443-f1be-4f94-85da-49aa603f54e42026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.0e2e00fa-c4c5-4de7-adf9-cd9786b970162026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacyc212c9d5-32d3-3c5f-e053-2a95a90af88b2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack4e8b9858-23a1-4363-b26f-ee6b9ff7ebf92026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack350c20b0-1879-d4cb-e063-6294a90a37f22026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvagen Pharma Limitedb1a12c83-74ab-febc-e053-2a95a90a14412026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
ndc (product): 72888-059
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC0863f340-4c7e-379a-e063-6394a90a758d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC26f8c3bc-4402-e92c-e063-6294a90a9ad72024-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMA-S Medication Solutionsbafff1ac-02fb-4726-b2d7-6e099ae981cb2023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAsclemed USA, Inc.9881dbb2-1ce2-4737-989f-b26720791ca52022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LP0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204237
application number: ANDA204237

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9101
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9101
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb1a12c83-74ab-febc-e053-2a95a90a14419
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb1a12c83-74ab-febc-e053-2a95a90a14419
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0e2e00fa-c4c5-4de7-adf9-cd9786b970167
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0e2e00fa-c4c5-4de7-adf9-cd9786b970167
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN4582d443-f1be-4f94-85da-49aa603f54e43
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD4582d443-f1be-4f94-85da-49aa603f54e43
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNc212c9d5-32d3-3c5f-e053-2a95a90af88b2
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0863f340-4c7e-379a-e063-6394a90a758d2
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN350c20b0-1879-d4cb-e063-6294a90a37f22
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD350c20b0-1879-d4cb-e063-6294a90a37f22
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDc212c9d5-32d3-3c5f-e053-2a95a90af88b2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0863f340-4c7e-379a-e063-6394a90a758d2
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN26f8c3bc-4402-e92c-e063-6294a90a9ad71
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9881dbb2-1ce2-4737-989f-b26720791ca51
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNbafff1ac-02fb-4726-b2d7-6e099ae981cb1
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD26f8c3bc-4402-e92c-e063-6294a90a9ad71
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9881dbb2-1ce2-4737-989f-b26720791ca51
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDbafff1ac-02fb-4726-b2d7-6e099ae981cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-059-307288800593030 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-059-30) 2017-06-010000-00-00NoNoCurrent
72888-059-907288800599090 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-059-90) 2017-06-010000-00-00NoNoCurrent