Cetirizine Hydrochloride (Allergy)
Cetirizine Hydrochloride Tablets (Allergy)
Approved
Approval ID
89db2c96-62f6-4e75-8f0d-321b44094c60
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
INNOVUS PHARMACEUTICALS, INC.
DUNS: 962507187
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cetirizine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57483-190
Application NumberANDA090760
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (9)
CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT