Members Mark Allergy Relief

Product NDC
68196-413
11-digit product format
681960413
Labeler code
68196
Product ID
68196-413_f8834e23-1240-4098-95f2-c8e31d6c2c64
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA078336
Marketing category
ANDA
Marketing start
2024-03-08
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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
Members Mark Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-413-79Members Mark Allergy Relief2 in 1 PACKAGETABLET, FILM COATED22
68196-413-82Members Mark Allergy Relief200 in 1 BOTTLETABLET, FILM COATED2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-413MEMBERS MARK ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SAM'S WEST INC]2Current NDC, 2 package rows20240516_379756fd-f92d-4773-94fd-2682fcbdfba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN379756fd-f92d-4773-94fd-2682fcbdfba22
1014678cetirizine hydrochloride 10 MG Oral TabletSCD379756fd-f92d-4773-94fd-2682fcbdfba22
1014678cetirizine HCl 10 MG Oral TabletSY379756fd-f92d-4773-94fd-2682fcbdfba22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-413-79681960413792 BOTTLE in 1 PACKAGE (68196-413-79) / 200 TABLET, FILM COATED in 1 BOTTLE (68196-413-82) 2 bottle2024-03-08NoNoCurrent
68196-413-8268196041382200 in 1 BOTTLEHistorical