FDA.reportPublic FDA data

Desloratadine

Product NDC
55111-360
11-digit product format
551110360
Labeler code
55111
Product ID
55111-360_ae8e6303-9bd6-d6de-79d6-d70b7b736c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078367
Marketing category
ANDA
Marketing start
2013-01-11
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078367-001DESLORATADINEDESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12
A078367-002DESLORATADINEDESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078367-001DESLORATADINE2.5MGTABLET, ORALLY DISINTEGRATING / ORAL2010-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078367-002DESLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRS2010-07-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078367-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078367-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A078367-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078367-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078367-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078367-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078367-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078367-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078367-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078367-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078367-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078367-002AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Desloratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESLORATADINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FVF865388RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403841Internal RxNorm lookup
577080Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5d1f465-e436-b4fd-d351-07a7b2acb440Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-360-06Desloratadine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610
55111-360-31Desloratadine5 in 1 CARTONTABLET, ORALLY DISINTEGRATING510
55111-360-31Desloratadine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-360-06EA - Each55111-360123252a3-8e23-4eb4-a6db-ed818ea6774612017-06-15
55111-360-31EA - Each55111-3605b2ac3fd-5b38-4170-b8df-7398a7907ca512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesloratadineACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
DesloratadineACTIVE MOIETYFVF865388RDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
crospovidoneINACTIVE INGREDIENT68401960MKDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ADESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
POLACRILININACTIVE INGREDIENTRCZ785HI7SDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UIDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-360DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]10Current NDC, Legacy NDC, 3 package rows20240530_e5d1f465-e436-b4fd-d351-07a7b2acb440.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
DesloratadineDESLORATADINEDr. Reddy's Laboratories Limitede5d1f465-e436-b4fd-d351-07a7b2acb4402024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078367
application number: ANDA078367
ndc (product): 55111-360

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577080desloratadine 2.5 MG Disintegrating Oral TabletPSNe5d1f465-e436-b4fd-d351-07a7b2acb44010
403841desloratadine 5 MG Disintegrating Oral TabletPSNe5d1f465-e436-b4fd-d351-07a7b2acb44010
577080desloratadine 2.5 MG Disintegrating Oral TabletSCDe5d1f465-e436-b4fd-d351-07a7b2acb44010
403841desloratadine 5 MG Disintegrating Oral TabletSCDe5d1f465-e436-b4fd-d351-07a7b2acb44010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-360-06551110360066 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06) 2013-01-110000-00-00NoNoCurrent
55111-360-31551110360315 BLISTER PACK in 1 CARTON (55111-360-31) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2013-01-110000-00-00NoNoCurrent