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FDA Drug information

Haloperidol

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230130

Version

7

Spl Product Data Elements

Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL 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 GREEN CAPSULE ZC;07 Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL 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 LIGHT GREEN CAPSULE ZC;08 Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL 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 CORAL CAPSULE ZC;09 Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 SILICON DIOXIDE STARCH, CORN OFF-WHITE 15;11 Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 SILICON DIOXIDE STARCH, CORN ALUMINUM OXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 PALE YELLOW 15;12 Haloperidol Haloperidol HALOPERIDOL HALOPERIDOL MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 SILICON DIOXIDE STARCH, CORN ALUMINUM OXIDE D&C RED NO. 27 ALUMINUM LAKE Light Pink 15;13

Application Number

ANDA077580

Brand Name

Haloperidol

Generic Name

Haloperidol

Product Ndc

65841-626

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

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 R x only 100 Tablets NDC 65841-628-01 in bottles of 100 tablets Haloperidol Tablets USP, 20 mg R x only 100 Tablets 0.5 mg label 1 mg label 2 mg label Haloperidol Tabs5mg Haloperidol Tabs10mg Haloperidol Tabs20mg

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