Cetirizine Hydrochloride (Allergy)
Approved
Approval ID
3d2eac7f-db44-4771-8c7e-a38e68a7f24b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 5, 2025
Manufacturers
FDA
WALGREEN CO.
DUNS: 008965063
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 Code0363-0068
Application NumberANDA209107
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2025
FDA Product Classification
INGREDIENTS (10)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT