Loratadine

Product NDC
50090-0836
11-digit product format
500900836
Labeler code
50090
Product ID
50090-0836_30a2cbb3-9526-43e3-95a7-cec6f4019e5d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076301
Marketing category
ANDA
Marketing start
2008-10-15
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
50090-0836-0Loratadineantihistamine10 in 1 BOTTLETABLET1023
50090-0836-1Loratadineantihistamine20 in 1 BOTTLETABLET2023
50090-0836-3Loratadineantihistamine15 in 1 BOTTLETABLET1523
50090-0836-4Loratadineantihistamine30 in 1 BOTTLETABLET3023
50090-0836-5Loratadineantihistamine90 in 1 BOTTLETABLET9023
50090-0836-6Loratadineantihistamine7 in 1 BOTTLETABLET723

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0836-0EA - Each50090-08364b7ec55d-080f-433c-86cc-a5cef28b20f812018-10-11
50090-0836-1EA - Each50090-0836abf7202f-d897-4f2c-972a-c7248b4e49b712018-10-11
50090-0836-3EA - Each50090-08362c00fa1f-536f-402f-a228-3224eab7077a12018-10-11
50090-0836-4EA - Each50090-08365c3a43ed-c0ad-465b-9c88-e55e7224794e12018-10-11
50090-0836-5EA - Each50090-083624327a74-a93f-4d1a-87be-a3aa9958819912018-10-11
50090-0836-6EA - Each50090-083641b53fb0-ef89-45fd-befd-867fc961c44a12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0836LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 6 package rows20250418_1203981a-becd-4854-810d-b6d8842b5bd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1203981a-becd-4854-810d-b6d8842b5bd223
311372loratadine 10 MG Oral TabletSCD1203981a-becd-4854-810d-b6d8842b5bd223
311372loratadine 10 MG 24 HR Oral TabletSY1203981a-becd-4854-810d-b6d8842b5bd223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0836-05009008360010 TABLET in 1 BOTTLE (50090-0836-0) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-0836-15009008360120 TABLET in 1 BOTTLE (50090-0836-1) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0836-35009008360315 TABLET in 1 BOTTLE (50090-0836-3) 15 tablet2014-11-280000-00-00NoNoCurrent
50090-0836-45009008360430 TABLET in 1 BOTTLE (50090-0836-4) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0836-55009008360590 TABLET in 1 BOTTLE (50090-0836-5) 90 tablet2014-11-280000-00-00NoNoCurrent
50090-0836-6500900836067 TABLET in 1 BOTTLE (50090-0836-6) 7 tablet2014-11-280000-00-00NoNoCurrent