Cetirizine Hydrochloride
Cetirizine Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL)
Approved
Approval ID
6d81446e-f713-4ca4-af38-3d31cf618873
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-4070
Application NumberANDA076601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 64O047KTOA
Classification: ACTIB