FDA.reportPublic FDA data

Members Mark Childrens Cetirizine

Product NDC
68196-475
11-digit product format
681960475
Labeler code
68196
Product ID
68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA204226
Marketing category
ANDA
Marketing start
2024-09-23
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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 Childrens Cetirizine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

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
68196-475-34Members Mark Childrens Cetirizine240 mL in 1 BOTTLESOLUTION2402
68196-475-43Members Mark Childrens Cetirizine2 in 1 CARTONSOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-475MEMBERS MARK CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [SAM'S WEST INC]2Current NDC, 2 package rows20241009_9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-475-3468196047534240 mL in 1 BOTTLE240 mlHistorical
68196-475-43681960475432 BOTTLE in 1 CARTON (68196-475-43) / 240 mL in 1 BOTTLE (68196-475-34) 2 bottle2024-09-23NoNoCurrent