MIPLYFFA Capsule Ref.[115507] Active ingredients: Arimoclomol

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

MIPLYFFA capsules contain arimoclomol citrate. Arimoclomol citrate is a crystalline powder of white to off-white color that is freely soluble in water. The chemical name is N-[(2R,Z)-2-hydroxy-3-(1piperidyl)propoxy]pyridine-3-carboximidoyl chloride, 1-oxide, citrate.

The empirical formula is C20H28ClN3O10 and the molecular weight is 505.90 g/mol. The chemical structure is:

MYPLIFFA contains 47 mg, 62 mg, 93 mg, or 124 mg of arimoclomol (equivalent to 75 mg, 100 mg, 150 mg, or 200 mg of arimoclomol citrate). The inactive ingredients are microcrystalline cellulose (MCC) and magnesium stearate. The inactive ingredients are not water soluble and will remain undissolved if the contents of the capsule are added to beverages or soft food [see Dosage and Administration (2.3)].

The capsule shells contain hypromellose, titanium dioxide, and one or more of the following: Brilliant Blue FCF-FD&C Blue 1, Yellow iron oxide and Red iron oxide.

Dosage Forms and Strengths

MIPLYFFA (arimoclomol) capsules are available as follows:

MIPLYFFA
Strength		Description of Capsules
47 mgWhite opaque body with black printing "47", and green opaque cap
with black printing "OZ"
62 mgWhite opaque body with black printing "62", and yellow opaque cap
with black printing "OZ"
93 mgWhite opaque body with black printing "93", and orange opaque cap
with black printing "OZ"
124 mgWhite opaque body with black printing "124", and red opaque cap
with black printing "OZ"
How Supplied

MIPLYFFA (arimoclomol) capsules are supplied in high-density polyethylene (HDPE) bottles with child-resistant closure as follows:

MIPLYFFA
Strength		Capsules DescriptionPackage ConfigurationNDC No.
47 mgWhite opaque body with black printing "47",
and green opaque cap with black printing
"OZ"		Bottle of 90 capsules72542-147-01
62 mgWhite opaque body with black printing "62",
and yellow opaque cap with black printing
"OZ".		Bottle of 90 capsules72542-162-01
93 mgWhite opaque body with black printing "93",
and orange opaque cap with black printing
"OZ"		Bottle of 90 capsules72542-193-01
124 mgWhite opaque body with black printing
"124", and red opaque cap with black
printing "OZ"		Bottle of 90 capsules72542-124-01

Manufactured by: Zevra Denmark A/S, 2000 Frederiksberg, Denmark

Manufactured for: Zevra Therapeutics, Inc., Celebration, FL 34747, USA

Drugs

Drug Countries
MIPLYFFA United States
 
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