Haloperidol (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 58657-702-01
Haloperidol
Tablets, USP
2 mg
Rx Only100 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-702-01 Haloperidol Tablets, USP 2 mg Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-702-10
Haloperidol
Tablets, USP
2 mg
Rx Only1000 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-702-10 Haloperidol Tablets, USP 2 mg Rx Only 1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-703-01
Haloperidol
Tablets, USP
5 mg
Rx Only100 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-703-01 Haloperidol Tablets, USP 5 mg Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-703-10
Haloperidol
Tablets, USP
5 mg
Rx Only1000 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-703-10 Haloperidol Tablets, USP 5 mg Rx Only 1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-704-01
Haloperidol
Tablets, USP
10 mg
Rx Only100 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-704-01 Haloperidol Tablets, USP 10 mg Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-704-10
Haloperidol
Tablets, USP
10 mg
Rx Only1000 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-704-10 Haloperidol Tablets, USP 10 mg Rx Only 1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-705-01
Haloperidol
Tablets, USP
20 mg
Rx Only100 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-705-01 Haloperidol Tablets, USP 20 mg Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58657-705-10
Haloperidol
Tablets, USP
20 mg
Rx Only1000 Tablets

PRINCIPAL DISPLAY PANEL NDC 58657-705-10 Haloperidol Tablets, USP 20 mg Rx Only 1000 Tablets
(click image for full-size original)
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-700
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 150;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-700-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-700-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 1 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 151;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-701-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-701-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-702
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 2 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 152;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-702-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-702-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-703
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 153;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-703-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-703-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-704
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color BLUE (Aqua) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 154;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-704-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-704-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-705
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C RED NO. 40
Product Characteristics
Color PINK (Salmon) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 155;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-705-01 100 TABLET in 1 BOTTLE None
2 NDC:58657-705-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 11/25/2019
Labeler — Method Pharmaceuticals, LLC (060216698)

Revised: 11/2019 Method Pharmaceuticals, LLC

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