Loratadine

Product NDC
50090-1454
11-digit product format
500901454
Labeler code
50090
Product ID
50090-1454_06ab4a12-31b8-435c-9988-f2e1ca56003c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077421
Marketing category
ANDA
Marketing start
2010-11-24
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1454-0Loratadine120 mL in 1 CARTONSOLUTION12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1454-0ML - Milliliter50090-14549e45b0b2-f209-4dbf-bfaa-1fb834aff46812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1454LORATADINE SOLUTION [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 1 package rows20231210_0f6fe391-8709-40f0-8f52-e3357e6ea4f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN0f6fe391-8709-40f0-8f52-e3357e6ea4f910
692783loratadine 1 MG/ML Oral SolutionSCD0f6fe391-8709-40f0-8f52-e3357e6ea4f910
692783loratadine 5 MG per 5 ML Oral SolutionSY0f6fe391-8709-40f0-8f52-e3357e6ea4f910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1454-050090145400120 mL in 1 CARTON (50090-1454-0) 120 ml2014-11-280000-00-00NoNoCurrent