FDA.reportPublic FDA data

Premier Value

Product NDC
68016-165
11-digit product format
680160165
Labeler code
68016
Product ID
68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmacy Value Alliance LLC
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
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
Premier Value
Brand name suffix
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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-165-00Premier Value Childrens Cetirizine120 mL in 1 BOTTLESOLUTION1205
68016-165-00Premier Value Childrens Cetirizine1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-165-00ML - Milliliter68016-165ed593a9a-4523-4723-be12-a21532d506d812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
CetirizineACTIVE MOIETYYO7261ME24PREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0PREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4PREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2
waterINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSTORTIUM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-165PREMIER VALUE CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [PHARMACY VALUE ALLIANCE LLC]4Current NDC, Legacy NDC, 2 package rows20170719_a4931f0b-86f2-42c5-b2df-b359bb46f44a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa4931f0b-86f2-42c5-b2df-b359bb46f44a5
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa4931f0b-86f2-42c5-b2df-b359bb46f44a5
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa4931f0b-86f2-42c5-b2df-b359bb46f44a5
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa4931f0b-86f2-42c5-b2df-b359bb46f44a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-165-00680160165001 BOTTLE in 1 CARTON (68016-165-00) / 120 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent