Rabeprazole sodium

Product NDC
13668-107
11-digit product format
136680107
Labeler code
13668
Product ID
13668-107_4bf4f1c6-0ee4-479e-892c-8956b711374f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202376
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
A202376-001RABEPRAZOLE 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
A202376-001AB

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 UTC2026-02A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202376-001RABEPRAZOLE SODIUM20MGTABLET, DELAYED RELEASE / ORALAB2013-11-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202376-001RABEPRAZOLE 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 UTC2026-02A202376-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202376-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202376-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202376-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202376-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202376-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202376-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202376-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202376-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202376-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202376-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202376-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202376-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202376-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202376-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202376-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202376-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202376-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202376-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202376-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202376-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202376-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202376-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202376-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202376-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202376-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202376-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202376-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202376-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202376-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202376-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202376-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202376-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202376-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202376-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202376-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202376-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202376-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202376-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202376-001AB1cb3db0bc1861…

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
04e88b86-e1dd-4c56-8359-45fbcc161f7dAvailable 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
13668-107-30Rabeprazole sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3017
13668-107-90Rabeprazole sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-107-05EA - Each13668-107ecfea035-e2df-499b-8cf0-546aaa38822112013-12-02
13668-107-30EA - Each13668-107dbe4e556-87fc-4ffb-9994-9fc9f4c5328a12013-12-02
13668-107-90EA - Each13668-1074ec18301-00d6-4fe2-9312-ffa2e35d375c12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ERABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1URABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ARABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ARABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ERABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ERABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1URABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1URABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-107RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 2 package rows20250112_04e88b86-e1dd-4c56-8359-45fbcc161f7d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole sodiumRABEPRAZOLE SODIUMTorrent Pharmaceuticals Limited04e88b86-e1dd-4c56-8359-45fbcc161f7d2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202376
application number: ANDA202376
ndc (product): 13668-107
Rabeprazole sodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.1855ccab-c377-4962-9225-3c5adc62e2bd2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202376
application number: ANDA202376
Rabeprazole sodiumRABEPRAZOLE SODIUMProficient Rx LPd1444508-fe40-4f68-8350-52f13399e38a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202376
application number: ANDA202376

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN04e88b86-e1dd-4c56-8359-45fbcc161f7d17
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD04e88b86-e1dd-4c56-8359-45fbcc161f7d17
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNea013e44-8b21-46c5-bedf-7e956a3b8aa57
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDea013e44-8b21-46c5-bedf-7e956a3b8aa57
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN8f896469-4df5-599c-e053-2a95a90ac9246
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD8f896469-4df5-599c-e053-2a95a90ac9246
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNd1444508-fe40-4f68-8350-52f13399e38a3
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDd1444508-fe40-4f68-8350-52f13399e38a3
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN1855ccab-c377-4962-9225-3c5adc62e2bd1
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD1855ccab-c377-4962-9225-3c5adc62e2bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-107-0513668010705500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-05) 2013-11-080000-00-00NoNoCurrent
13668-107-301366801073030 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30) 2013-11-080000-00-00NoNoCurrent
13668-107-40136680107404000 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-40) 2013-11-080000-00-00NoNoCurrent
13668-107-7413668010774100 TABLET, DELAYED RELEASE in 1 CARTON (13668-107-74) 2013-11-080000-00-00NoNoCurrent
13668-107-901366801079090 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-90) 2013-11-080000-00-00NoNoCurrent