Haloperidol (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-152-01

Haloperidol Tablets USP, 2 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label3
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-153-01

Haloperidol Tablets USP, 5 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label4
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-154-01

Haloperidol Tablets USP, 10 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label5
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-155-01

Haloperidol Tablets USP, 20 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label6
(click image for full-size original)

HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-150
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-150-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-150-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-151
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-151-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-151-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-152
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-152-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-152-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-153
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-153-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-153-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-154
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color TURQUOISE (AQUA) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code I;154
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-154-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-154-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
HALOPERIDOL haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-155
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
FD&C RED NO. 40
Product Characteristics
Color PINK (SALMON) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code I;155
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-155-01 100 TABLET in 1 BOTTLE None
2 NDC:71247-155-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 02/18/2021
Labeler — Innogenix, Inc. (080501434)
Establishment
Name Address ID/FEI Operations
Innogenix, LLC 044649124 ANALYSIS (71247-150), ANALYSIS (71247-151), ANALYSIS (71247-152), ANALYSIS (71247-153), ANALYSIS (71247-154), ANALYSIS (71247-155), LABEL (71247-150), LABEL (71247-151), LABEL (71247-152), LABEL (71247-153), LABEL (71247-154), LABEL (71247-155), MANUFACTURE (71247-150), MANUFACTURE (71247-151), MANUFACTURE (71247-152), MANUFACTURE (71247-153), MANUFACTURE (71247-154), MANUFACTURE (71247-155), PACK (71247-150), PACK (71247-151), PACK (71247-152), PACK (71247-153), PACK (71247-154), PACK (71247-155)

Revised: 02/2021 Innogenix, Inc.

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