Desloratadine

Product NDC
62756-523
11-digit product format
627560523
Labeler code
62756
Product ID
62756-523_b5875e34-88ab-4ffc-b9b2-7281ec549566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078359
Marketing category
ANDA
Marketing start
2010-11-24
Marketing end
0000-00-00
Substance
DESLORATADINE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62756-523IInactivated by FDA2026-08-17
excluded packagepackage62756-52362756-523-08IInactivated by FDA2026-08-17
excluded packagepackage62756-52362756-523-13IInactivated by FDA2026-08-17
excluded packagepackage62756-52362756-523-18IInactivated by FDA2026-08-17
excluded packagepackage62756-52362756-523-83IInactivated by FDA2026-08-17
excluded packagepackage62756-52362756-523-88IInactivated by FDA2026-08-17

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 2 · 114 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62756-523-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62756-523-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62756-523-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62756-523-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62756-523-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62756-523-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62756-523-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62756-523-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62756-523-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62756-523-88f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62756-523-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62756-523-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62756-523-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62756-523-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62756-523-882ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62756-523-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62756-523-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62756-523-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62756-523-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62756-523-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62756-523-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62756-523-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62756-523-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62756-523-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62756-523-88cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62756-523-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62756-523-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62756-523-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62756-523-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62756-523-88cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-523-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-523-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-523-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-523-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-523-88302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-523-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-523-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-523-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-523-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-523-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-523-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-523-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-523-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-523-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-523-880efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-523-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-523-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-523-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-523-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-523-88ad56d346431e…cc804d4bbf1e…

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
A078359-001DESLORATADINEDESLORATADINE5MGTABLET / ORAL2010-11-16

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 06:07:402026-07A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A078359-001DESLORATADINE5MGTABLET / ORALAB2010-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078359-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078359-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078359-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078359-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078359-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078359-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078359-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078359-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01632a31-f1c5-44ea-aa59-efded68c0797Product name120150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-523-08Desloratadine100 in 1 BOTTLETABLET, FILM COATED1008
62756-523-13Desloratadine500 in 1 BOTTLETABLET, FILM COATED5008
62756-523-18Desloratadine1000 in 1 BOTTLETABLET, FILM COATED10008
62756-523-83Desloratadine30 in 1 BOTTLETABLET, FILM COATED308
62756-523-88Desloratadine100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-523-13EA - Each62756-5230ca4dd9a-72cc-46c7-b3c9-003a918d956012013-02-13
62756-523-88EA - Each62756-523f26d77ba-d297-4ec0-ad5c-fab72c570edf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
DESLORATADINEACTIVE MOIETYFVF865388RDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-523DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Legacy NDC, 5 package rows20190508_58ba2dc8-10c2-4532-92e2-40ec2fee3378.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSN58ba2dc8-10c2-4532-92e2-40ec2fee33788
349420desloratadine 5 MG Oral TabletSCD58ba2dc8-10c2-4532-92e2-40ec2fee33788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62756-523-0862756052308100 in 1 BOTTLEHistorical
62756-523-1362756052313500 in 1 BOTTLEHistorical
62756-523-18627560523181000 in 1 BOTTLEHistorical
62756-523-836275605238330 in 1 BOTTLEHistorical
62756-523-8862756052388100 in 1 BOTTLEHistorical