HALOPERIDOL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)

Tillgänglig från:

Zydus Lifesciences Limited

INN (International namn):

HALOPERIDOL

Sammansättning:

HALOPERIDOL 5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this d

Produktsammanfattning:

Haloperidol Tablets USP, 5 mg are green, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '07' and partial bisect, on one side and plain on the other side and are supplied as follows: NDC 65841-626-01 in bottles of 100 tablets NDC 65841-626-10 in bottles of 1000 tablets Haloperidol Tablets USP, 10 mg are light green, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '08' and partial bisect, on one side and plain on the other side and are supplied as follows: NDC 65841-627-06 in bottles of 30 tablets NDC 65841-627-01 in bottles of 100 tablets NDC 65841-627-10 in bottles of 1000 tablets Haloperidol Tablets USP, 20 mg are coral, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '09' and bisect on one side and plain on the other side and are supplied as follows: NDC 65841-628-06 in bottles of 30 tablets NDC 65841-628-01 in bottles of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. All trademarks are the property of Zydus group. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HALOPERIDOL - HALOPERIDOL TABLET
ZYDUS LIFESCIENCES LIMITED
----------
HALOPERIDOL TABLETS, USP
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 only
100 Tablets
NDC 65841-628-01 in bottles of 100 tablets
Haloperidol Tablets USP, 20 mg
R only
100 Tablets
x
x
HALOPERIDOL
haloperidol tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-626
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)
HALOPERIDOL
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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
Z C;07
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
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 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