FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
55289-728
11-digit product format
552890728
Labeler code
55289
Product ID
55289-728_4d61c38c-3562-15bd-e063-6294a90a7ada
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-728-15Loratadine Allergy Relief15 in 1 BOTTLE, PLASTICTABLET1519
55289-728-20Loratadine Allergy Relief20 in 1 BOTTLE, PLASTICTABLET2019
55289-728-60Loratadine Allergy Relief60 in 1 BOTTLE, PLASTICTABLET6019
55289-728-90Loratadine Allergy Relief90 in 1 BOTTLE, PLASTICTABLET9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-728-15EA - Each55289-728522eb8b0-f69c-4998-97a7-8c7229a3e02312021-04-08
55289-728-20EA - Each55289-7284c842d7d-ca6c-4712-8a90-2f007f57582912021-04-08
55289-728-30EA - Each55289-728fd8b575b-847b-460b-a3ab-68e5a6c0a2cb12018-09-05
55289-728-60EA - Each55289-728e1d3bd6c-1cd0-4432-b28c-ff30eefb7d7312023-02-06
55289-728-90EA - Each55289-7283a5f0504-e2b7-4ca5-854c-d36ee178922912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-728LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 4 package rows20240314_7127b39d-3686-4249-b720-43c02b4c4654.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN7127b39d-3686-4249-b720-43c02b4c465419
311372loratadine 10 MG Oral TabletSCD7127b39d-3686-4249-b720-43c02b4c465419
311372loratadine 10 MG 24 HR Oral TabletSY7127b39d-3686-4249-b720-43c02b4c465419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-728-105528907281010 TABLET in 1 BOTTLE, PLASTIC (55289-728-10) 10 tablet2020-09-300000-00-00NoNoCurrent
55289-728-155528907281515 TABLET in 1 BOTTLE, PLASTIC (55289-728-15) 15 tablet2021-03-270000-00-00NoNoCurrent
55289-728-205528907282020 TABLET in 1 BOTTLE, PLASTIC (55289-728-20) 20 tablet2021-03-270000-00-00NoNoCurrent
55289-728-305528907283030 TABLET in 1 BOTTLE, PLASTIC (55289-728-30) 30 tablet2018-04-060000-00-00NoNoCurrent
55289-728-605528907286060 TABLET in 1 BOTTLE, PLASTIC (55289-728-60) 60 tablet2023-01-18NoNoHistorical
55289-728-905528907289090 TABLET in 1 BOTTLE, PLASTIC (55289-728-90) 90 tablet2018-04-060000-00-00NoNoCurrent