Cetirizine Hydrochloride
Approved
Approval ID
7f80130b-1759-46a1-b8ff-3f579a084e4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4288
Application NumberANDA078398
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2017
FDA Product Classification
INGREDIENTS (9)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 64O047KTOA
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT