Desloratadine Oral Solution

Product NDC
74157-011
11-digit product format
741570011
Labeler code
74157
Product ID
74157-011_41d5e0d4-6189-847b-e063-6294a90a2e2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
INA Pharmaceutics, Inc.
Application
ANDA202936
Marketing category
ANDA
Marketing start
2025-07-01
Substance
DESLORATADINE
Active strength
.5 mg/mL
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 Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESLORATADINE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFVF865388R
Rxcui607573

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
74157-011-01Desloratadine Oral Solution118 mL in 1 BOTTLESOLUTION1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74157-011-01ML - Milliliter74157-01132978ae8-235c-4f0e-8eba-9100ffd8e5c212025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607573desloratadine 0.5 MG in 1 mL Oral SolutionPSN41d5e0d4-6188-847b-e063-6294a90a2e2f1
607573desloratadine 0.5 MG/ML Oral SolutionSCD41d5e0d4-6188-847b-e063-6294a90a2e2f1
607573desloratadine 0.5 MG per 1 ML Oral SolutionSY41d5e0d4-6188-847b-e063-6294a90a2e2f1
607573desloratadine 2.5 MG per 5 ML Oral SolutionSY41d5e0d4-6188-847b-e063-6294a90a2e2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74157-011-0174157001101118 mL in 1 BOTTLE (74157-011-01) 118 ml2025-07-01NoNoHistorical