Haloperidol

HALOPERIDOL — haloperidol tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-837-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 0.5 mg

Rx only

100 Tablets

0.5 mg label
(click image for full-size original)

NDC 65841-838-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 1 mg

Rx only

100 Tablets

1 mg label
(click image for full-size original)

NDC 65841-839-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 2 mg

Rx only

100 Tablets

2 mg label
(click image for full-size original)

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
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-837
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
MICROCRYSTALLINE CELLULOSE 102
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (OFF-WHITE) Score score with uneven pieces
Shape ROUND Size 6mm
Flavor Imprint Code 15;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-837-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-837-10 1000 TABLET in 1 BOTTLE None
3 NDC:65841-837-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-837-30)
3 NDC:65841-837-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-837-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 1 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SILICON DIOXIDE
STARCH, CORN
ALUMINUM OXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color WHITE (PALE YELLOW) Score score with uneven pieces
Shape ROUND Size 6mm
Flavor Imprint Code 15;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-838-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-838-10 1000 TABLET in 1 BOTTLE None
3 NDC:65841-838-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-838-30)
3 NDC:65841-838-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-838-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 2 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SILICON DIOXIDE
STARCH, CORN
ALUMINUM OXIDE
D&C RED NO. 27 ALUMINUM LAKE
Product Characteristics
Color PINK (Light Pink) Score score with uneven pieces
Shape ROUND Size 7mm
Flavor Imprint Code 15;13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-839-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-839-10 1000 TABLET in 1 BOTTLE None
3 NDC:65841-839-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-839-30)
3 NDC:65841-839-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-839-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077580 02/01/2023
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-626), ANALYSIS (65841-627), ANALYSIS (65841-628), ANALYSIS (65841-837), ANALYSIS (65841-838), ANALYSIS (65841-839), MANUFACTURE (65841-626), MANUFACTURE (65841-627), MANUFACTURE (65841-628), MANUFACTURE (65841-837), MANUFACTURE (65841-838), MANUFACTURE (65841-839)

Revised: 01/2023 Zydus Lifesciences Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.