Hydroxyzine Hydrochloride
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
4789b7ae-314c-43c0-ad33-92ff50085f27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydroxyzine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43063-943
Application NumberANDA040786
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT