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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-153-01

Haloperidol Tablets USP, 5 mg

100 Tablets

Rx Only

Innogenix, LLC.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-154-01

Haloperidol Tablets USP, 10 mg

100 Tablets

Rx Only

Innogenix, LLC.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-155-01

Haloperidol Tablets USP, 20 mg

100 Tablets

Rx Only

Innogenix, LLC.

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.