Source: FDA, National Drug Code (US) Revision Year: 2020
AUSTEDO (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)3(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.
The molecular formula for deutetrabenazine is C19H21D6NO3.
Deutetrabenazine is a racemic mixture containing the following structures:
Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.
AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, n-butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.
| Dosage Forms and Strengths |
|---|
|
AUSTEDO tablets are available in the following strengths:
|
| How Supplied |
|---|
|
AUSTEDO tablets are available in the following strengths and packages: 6 mg: round, purple-coated tablets, with “SD” over “6” printed in black ink on one side. Bottles of 60 tablets: NDC 68546-170-60. 9 mg: round, blue-coated tablets, with “SD” over “9” printed in black ink on one side. Bottles of 60 tablets: NDC 68546-171-60. 12 mg: round, beige-coated tablets, with “SD” over “12” printed in black ink on one side. Bottles of 60 tablets: NDC 68546-172-60. |
| Drug | Countries | |
|---|---|---|
| AUSTEDO | Israel, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
