FDA.reportPublic FDA data

members mark allergy relief

Product NDC
68196-711
11-digit product format
681960711
Labeler code
68196
Product ID
68196-711_566fe04e-ac31-4aef-9ec2-25756f03fb53
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA076301
Marketing category
ANDA
Marketing start
2024-03-11
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
members mark allergy relief
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
68196-711-79members mark allergy relief200 in 1 BOTTLETABLET2002
68196-711-79members mark allergy relief2 in 1 PACKAGETABLET22
68196-711-82members mark allergy relief200 in 1 BOTTLETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-711MEMBERS MARK ALLERGY RELIEF (LORATADINE) TABLET [SAM'S WEST INC]2Current NDC, 3 package rows20240406_95c2b45a-d0e5-467c-aad4-7bbb6c9a5204.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN95c2b45a-d0e5-467c-aad4-7bbb6c9a52042
311372loratadine 10 MG Oral TabletSCD95c2b45a-d0e5-467c-aad4-7bbb6c9a52042
311372loratadine 10 MG 24 HR Oral TabletSY95c2b45a-d0e5-467c-aad4-7bbb6c9a52042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-711-79681960711792 BOTTLE in 1 PACKAGE (68196-711-79) / 200 TABLET in 1 BOTTLE2 bottle2024-03-11NoNoCurrent
68196-711-8268196071182200 TABLET in 1 BOTTLE (68196-711-82) 200 tablet2024-03-11NoNoCurrent