Benazepril Hydrochloride and Hydrochlorothiazide (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg

100 TABLETS

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BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
benazepril hydrochloride and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0227
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (light pink) Score 2 pieces
Shape OVAL (OBLONG) Size 12mm
Flavor Imprint Code LOTENSIN;HCT;452
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0227-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020033 04/07/2019
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
benazepril hydrochloride and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PURPLE (GRAYISH-VIOLET) Score 2 pieces
Shape OVAL (OBLONG) Size 12mm
Flavor Imprint Code LOTENSIN;HCT;453
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0229-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020033 04/07/2019
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
benazepril hydrochloride and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0228
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color RED Score 2 pieces
Shape OVAL (OBLONG) Size 12mm
Flavor Imprint Code LOTENSIN;HCT;454
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0228-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020033 04/07/2019
Labeler — Padagis US LLC (967694121)

Revised: 05/2023 Padagis US LLC

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