FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
70752-103
11-digit product format
707520103
Labeler code
70752
Product ID
70752-103_eb119bad-6e21-4378-a556-41b1b790d84c
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA212266
Marketing category
ANDA
Marketing start
2022-10-15
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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
CETIRIZINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-103-062025-12-26C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062025-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062023-02-02C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062023-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-103-06CETIRIZINE HYDROCHLORIDE1 in 1 CARTONSOLUTION19
70752-103-06CETIRIZINE HYDROCHLORIDE118 mL in 1 BOTTLE, PLASTICSOLUTION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-103CETIRIZINE HYDROCHLORIDE SOLUTION [QUAGEN PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 2 package rows20230519_9163cd2e-0be7-4009-b905-729014773d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9163cd2e-0be7-4009-b905-729014773d6e9
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9163cd2e-0be7-4009-b905-729014773d6e9
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9163cd2e-0be7-4009-b905-729014773d6e9
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9163cd2e-0be7-4009-b905-729014773d6e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70752-103-06707520103061 BOTTLE, PLASTIC in 1 CARTON (70752-103-06) / 118 mL in 1 BOTTLE, PLASTIC2022-10-150000-00-00NoNoCurrent