fluphenazine hydrochloride tablet film coated

INDICATIONS AND USAGE Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.

amneal pharmaceuticals ny llc

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] off label use` `[3] drug ineffective` `[4] toxicity to various agents` `[5] completed suicide` `[6] diarrhoea` `[7] fatigue` `[8] drug abuse` `[9] nausea` `[10] headache`

4 years ago

ROUND ORANGE E2

HOW SUPPLIED Fluphenazine Hydrochloride Tablets, USP are available containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride, USP. Fluphenazine Hydrochloride Tablets USP, 1 mg are supplied as white to off-white colored, round shaped, film-coated tablets debossed with "D5" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1678-1 Fluphenazine Hydrochloride Tablets USP, 2.5 mg are supplied as yellow colored, round shaped, film-coated tablets debossed with "E4" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1679-1 Fluphenazine Hydrochloride Tablets USP, 5 mg are supplied as green colored, round shaped, film-coated tablets debossed with "E1" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1680-1 Fluphenazine Hydrochloride Tablets USP, 10 mg are supplied as orange to light orange colored, round shaped, film-coated tablets debossed with "E2" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 60219-1681-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2020-01

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