FDA.reportPublic FDA data

Desloratadine

Product NDC
55111-551
11-digit product format
551110551
Labeler code
55111
Product ID
55111-551_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
2.5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESLORATADINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFVF865388R
Rxcui403841, 577080

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
55111-551-06Desloratadine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610
55111-551-31Desloratadine5 in 1 CARTONTABLET, ORALLY DISINTEGRATING510
55111-551-31Desloratadine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-551-06EA - Each55111-5512a720afc-162d-48be-949a-def1acb6977012017-06-15
55111-551-31EA - Each55111-551a18948f4-aed6-4c2a-8ad4-4828038c9ccf12013-02-13

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
55111-551DESLORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES LIMITED]10Current NDC, Legacy NDC, 3 package rows20240530_e5d1f465-e436-b4fd-d351-07a7b2acb440.zip

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
55111-551-06551110551066 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-551-06) 2013-01-110000-00-00NoNoCurrent
55111-551-31551110551315 BLISTER PACK in 1 CARTON (55111-551-31) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2013-01-110000-00-00NoNoCurrent