HALOPERIDOL- haloperidol tablet 
Cadila Healthcare Limited

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Haloperidol Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-626-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 5 mg

Rx only

100 Tablets

Haloperidol Tabs5mg

NDC 65841-627-01 in bottles of 100 tablets

Haloperidol Tablets USP, 10 mg

Rx only

100 Tablets

Haloperidol Tabs10mg

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

Rx only

100 Tablets

Haloperidol Tabs20mg
HALOPERIDOL 
haloperidol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-626
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (GREEN) Score2 pieces
ShapeOVAL (CAPSULE) Size10mm
FlavorImprint Code ZC;07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-626-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
2NDC:65841-626-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758001/03/2008
HALOPERIDOL 
haloperidol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (LIGHT GREEN) Score2 pieces
ShapeOVAL (CAPSULE) Size10mm
FlavorImprint Code ZC;08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-627-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
2NDC:65841-627-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758001/03/2008
HALOPERIDOL 
haloperidol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (CORAL) Score2 pieces
ShapeOVAL (CAPSULE) Size10mm
FlavorImprint Code ZC;09
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-628-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
2NDC:65841-628-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758001/03/2008
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-626, 65841-627, 65841-628) , MANUFACTURE(65841-626, 65841-627, 65841-628)

Revised: 7/2020
Document Id: 53e86039-1c17-49e8-ac39-1a54591b2981
Set id: 509d0eb2-b930-4836-9669-dbebf0ac4076
Version: 5
Effective Time: 20200728
 
Cadila Healthcare Limited