Haloperidol

HALOPERIDOL- haloperidol tablet
Cadila Healthcare Limited

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
(click image for full-size original)

NDC 65841-627-01 in bottles of 100 tablets

Haloperidol Tablets USP, 10 mg

Rx only

100 Tablets

Haloperidol Tabs10mg
(click image for full-size original)

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

Rx only

100 Tablets

Haloperidol Tabs20mg
(click image for full-size original)
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-626
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
ALUMINUM OXIDE
CALCIUM STEARATE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1–ALUMINUM LAKE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color GREEN (GREEN) Score 2 pieces
Shape OVAL (CAPSULE) Size 10mm
Flavor Imprint Code ZC;07
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-626-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-626-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1–ALUMINUM LAKE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
ALUMINUM OXIDE
Product Characteristics
Color GREEN (LIGHT GREEN) Score 2 pieces
Shape OVAL (CAPSULE) Size 10mm
Flavor Imprint Code ZC;08
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-627-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-627-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
D&C RED NO. 27 ALUMINUM LAKE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color ORANGE (CORAL) Score 2 pieces
Shape OVAL (CAPSULE) Size 10mm
Flavor Imprint Code ZC;09
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-628-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-628-06 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077580 01/03/2008
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-626), ANALYSIS (65841-627), ANALYSIS (65841-628), MANUFACTURE (65841-626), MANUFACTURE (65841-627), MANUFACTURE (65841-628)

Revised: 07/2020 Cadila Healthcare Limited

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