Hydroxyzine (Page 2 of 2)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 0904-0358-60
HydrOXYzine HCL
Tablets, USP
25mg
Rx Only100 Tablets

NDC 0904-0358-60 HydrOXYzine HCL Tablets, USP 25mg Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0904-0359-60
HydrOXYzine HCL
Tablets, USP
50mg
Rx Only100 Tablets

NDC 0904-0359-60 HydrOXYzine HCL Tablets, USP 50mg Rx Only 100 Tablets
(click image for full-size original)
HYDROXYZINE hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-0357(NDC:10702-010)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 3350
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code K;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-0357-40 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0904-0357-60 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040786 03/20/2007 11/30/2012
HYDROXYZINE hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-0358(NDC:10702-011)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CARNAUBA WAX
CROSPOVIDONE (15 MPA.S AT 5%)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code K;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-0358-40 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0904-0358-60 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0904-0358-80 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040787 03/20/2007
HYDROXYZINE hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-0359(NDC:10702-012)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 3350
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code K;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-0359-60 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040788 03/20/2007
Labeler — Major Pharmaceuticals (191427277)

Revised: 08/2018 Major Pharmaceuticals

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