FDA.reportPublic FDA data

Desloratadine

Product NDC
72162-2308
11-digit product format
721622308
Labeler code
72162
Product ID
72162-2308_52ff3486-b017-428a-945a-743810c38e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078355
Marketing category
ANDA
Marketing start
2015-06-12
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
72162-2308-1Desloratadine100 in 1 BOTTLE, PLASTICTABLET100102
72162-2308-3Desloratadine30 in 1 BOTTLE, PLASTICTABLET30102
72162-2308-5Desloratadine500 in 1 BOTTLE, PLASTICTABLET500102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2308-1EA - Each72162-23084ba93093-d5fb-4cda-9c84-b9852fa7117a12024-06-10
72162-2308-3EA - Each72162-2308ab83f108-f697-4abb-a82b-5f3ef36cc11d12024-10-04
72162-2308-5EA - Each72162-2308f2088eab-6153-4d2c-9a7c-40acc4eca90c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2308DESLORATADINE TABLET [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20240606_cf7f838b-4595-4c81-97b9-e1594347e1bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSNcf7f838b-4595-4c81-97b9-e1594347e1bd102
349420desloratadine 5 MG Oral TabletSCDcf7f838b-4595-4c81-97b9-e1594347e1bd102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2308-172162230801100 TABLET in 1 BOTTLE, PLASTIC (72162-2308-1) 100 tablet2024-05-07NoNoCurrent
72162-2308-37216223080330 TABLET in 1 BOTTLE, PLASTIC (72162-2308-3) 30 tablet2024-05-07NoNoCurrent
72162-2308-572162230805500 TABLET in 1 BOTTLE, PLASTIC (72162-2308-5) 500 tablet2024-05-07NoNoCurrent