FDA.reportPublic FDA data

DESLORATADINE

Product NDC
68180-153
11-digit product format
681800153
Labeler code
68180
Product ID
68180-153_816c977e-5e34-42e0-ba3d-c8060f8cfa17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESLORATADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078352
Marketing category
ANDA
Marketing start
2013-02-25
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

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 Identifiers#

Field, Values table
FieldValues
UniiFVF865388R
Rxcui349420

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
68180-153-01DESLORATADINE100 in 1 BOTTLETABLET, FILM COATED10016
68180-153-02DESLORATADINE500 in 1 BOTTLETABLET, FILM COATED50016
68180-153-03DESLORATADINE1000 in 1 BOTTLETABLET, FILM COATED100016
68180-153-06DESLORATADINE30 in 1 BOTTLETABLET, FILM COATED3016
68180-153-11DESLORATADINE10 in 1 BLISTER PACKTABLET, FILM COATED1016
68180-153-12DESLORATADINE3 in 1 CARTONTABLET, FILM COATED316
68180-153-12DESLORATADINE10 in 1 BLISTER PACKTABLET, FILM COATED1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-153-01EA - Each68180-1530973f287-d02e-4f00-a8ea-e972acc41a4212014-01-04
68180-153-02EA - Each68180-15344583757-cf3b-448b-b7fe-71527c05c85b12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]3
DESLORATADINEACTIVE MOIETYFVF865388RDESLORATADINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-153DESLORATADINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 7 package rows20240124_2a90b899-7746-43dc-ac8a-e754428eb30c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSN2a90b899-7746-43dc-ac8a-e754428eb30c16
349420desloratadine 5 MG Oral TabletSCD2a90b899-7746-43dc-ac8a-e754428eb30c16
349420desloratadine 5 MG Oral TabletPSN69b9635b-c790-4316-a790-67b0f5512b7212
349420desloratadine 5 MG Oral TabletSCD69b9635b-c790-4316-a790-67b0f5512b7212
349420desloratadine 5 MG Oral TabletPSNa3b61ab9-ec20-4831-b69a-fcd913fce5403
349420desloratadine 5 MG Oral TabletSCDa3b61ab9-ec20-4831-b69a-fcd913fce5403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-153-0168180015301100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01) 2013-02-250000-00-00NoNoCurrent
68180-153-0268180015302500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02) 2013-02-250000-00-00NoNoCurrent
68180-153-03681800153031000 TABLET, FILM COATED in 1 BOTTLE (68180-153-03) 2013-02-250000-00-00NoNoCurrent
68180-153-066818001530630 TABLET, FILM COATED in 1 BOTTLE (68180-153-06) 2013-02-250000-00-00NoNoCurrent
68180-153-116818001531110 in 1 BLISTER PACKHistorical
68180-153-12681800153123 BLISTER PACK in 1 CARTON (68180-153-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-153-11) 3 blister pack2013-02-250000-00-00NoNoCurrent
68180-153-136818001531310 BLISTER PACK in 1 CARTON (68180-153-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-153-11) 10 blister pack2013-02-250000-00-00NoNoCurrent