PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-837-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 0.5 mg

Rx only

100 Tablets

NDC 65841-838-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 1 mg

Rx only

100 Tablets

NDC 65841-839-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 2 mg

Rx only

100 Tablets

NDC 65841-626-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 5 mg

Rx only

100 Tablets

NDC 65841-627-01 in bottles of 100 tablets

Haloperidol Tablets USP, 10 mg

Rx only

100 Tablets

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

Rx only

100 Tablets

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-626
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
CALCIUM STEARATE (UNII: 776XM7047L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	GREEN (GREEN)	Score	2 pieces
Shape	OVAL (CAPSULE)	Size	10mm
Flavor		Imprint Code	ZC;07
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-626-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008
2	NDC:65841-626-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	01/03/2008

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-627
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	10 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM STEARATE (UNII: 776XM7047L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	GREEN (LIGHT GREEN)	Score	2 pieces
Shape	OVAL (CAPSULE)	Size	10mm
Flavor		Imprint Code	ZC;08
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-627-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008
2	NDC:65841-627-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	01/03/2008

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-628
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	20 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM STEARATE (UNII: 776XM7047L)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	ORANGE (CORAL)	Score	2 pieces
Shape	OVAL (CAPSULE)	Size	10mm
Flavor		Imprint Code	ZC;09
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-628-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008
2	NDC:65841-628-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	01/03/2008

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-837
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (OFF-WHITE)	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	15;11
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-837-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC:65841-837-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC:65841-837-77	10 in 1 CARTON	02/01/2023
3	NDC:65841-837-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	02/01/2023

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-838
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	1 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	WHITE (PALE YELLOW)	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	15;12
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-838-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC:65841-838-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC:65841-838-77	10 in 1 CARTON	02/01/2023
3	NDC:65841-838-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	02/01/2023

HALOPERIDOL
haloperidol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-839
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)	HALOPERIDOL	2 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)

Product Characteristics
Color	PINK (Light Pink)	Score	score with uneven pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	15;13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-839-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC:65841-839-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC:65841-839-77	10 in 1 CARTON	02/01/2023
3	NDC:65841-839-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077580	02/01/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839) , MANUFACTURE(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839)

Haloperidol Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL