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Active ingredient

Tetrabenazine

24 finished FDA listings contain Tetrabenazine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TETRABENAZINE, TETRABENAZINE, (+)-
Dosage forms
Tablet, Tablet, Coated
Routes
Oral
Manufacturers / labelers
12
Strengths listed
12.5 mg/1 · 25 mg/1
Brand names in FDA listings
Xenazine

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10390

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021894BAUSCH2008-08-154
ANDA 206129SUN PHARM2015-08-172
ANDA 204574HETERO LABS LTD V2016-02-032
ANDA 207682MYLAN2017-01-312
ANDA 208826BIONPHARMA2017-12-182
ANDA 209284DR REDDYS2018-01-082
ANDA 213316ADAPTIS2020-01-224
ANDA 206093APOTEX2020-03-174
ANDA 213621AJANTA PHARMA LTD2020-12-042

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.