deutetrabenazine 9 MG Oral Tablet Austedo
1 INDICATIONS AND USAGE AUSTEDO ® XR and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )
teva neuroscience, inc.
ROUND BLUE SD 9
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied AUSTEDO XR extended-release tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg round, grey-coated tablets, with “Q6” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-470-56 12 mg round, blue-coated tablets, with “Q12” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-471-56 18 mg round, light grey-coated tablets, with “Q18” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-479-56 24 mg round, purple-coated tablets, with “Q24” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-472-56 30 mg round, light orange-coated tablets, with “Q30” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-473-56 36 mg round, light purple-coated tablets, with “Q36” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-474-56 42 mg round, orange-coated tablets, with “Q42” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-475-56 48 mg round, pink-coated tablets, with “Q48” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-476-56 AUSTEDO XR Patient Titration Kits are supplied in the following configuration: Strength Description Package Configuration NDC Code 4-Week Patient Titration Kit 12 mg round, blue-coated tablets, with “Q12” printed in black ink on one side Titration Kit / 28 count Each Titration Kit contains 1 child-resistant blister pack, containing one foil card with extended-release tablets in the following configuration: Seven 12 mg tablets taken during Week 1; seven 18 mg tablets taken during Week 2; seven 24 mg tablets taken during Week 3; and seven 30 mg tablets taken during Week 4. 68546-477-29 18 mg round, light grey-coated tablets, with “Q18” printed in black ink on one side 24 mg round, purple-coated tablets, with “Q24” printed in black ink on one side 30 mg round, light orange-coated tablets, with “Q30” printed in black ink on one side AUSTEDO tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg round, purple-coated tablets, with “SD” over “6” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-170-60 9 mg round, blue-coated tablets, with “SD” over “9” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-171-60 12 mg round, beige-coated tablets, with “SD” over “12” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-172-60 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light and moisture. Dispense in original containers or in tight containers as defined in USP.
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