Austedo (deutetrabenazine) NDC 68546-170

NDC codes

FDA NDC Directory

Product NDC (as listed)68546-170Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68546-0170Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68546-170-60	68546017060	60 TABLET, COATED in 1 BOTTLE (68546-170-60)Marketed from Apr 12, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Austedo
Generic name (nonproprietary): deutetrabenazine
Active ingredients: Deutetrabenazine — 6 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Teva Neuroscience, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208082
Marketing start: Apr 12, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 68546-170_69071a25-792d-4eec-a12a-1bb30c8fc881SPL ID 69071a25-792d-4eec-a12a-1bb30c8fc881SPL set ID 7ea3c60a-45c7-44cc-afc2-d87fa53993c0RxCUI 1876910, 1876916, 1876918, 1876920, 1876922, 1876924, 2281114, 2281115, 2281116, 2281117, 2541518, 2541519, 2541520, 2630144, 2630147, 2630150, 2630153, 2630155, 2630157, 2630159, 2630160, 2683282, 2683285, 2683288, 2683291, 2683294, 2683297, 2683300, 2683303, 2686153, 2686156, 2686612, 2686613UNII P341G6W9NBUPC 0368546172606, 0368546170602, 0368546171609

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468546017060 followed by a unit qualifier and the quantity

Package 68546-0170-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208082

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208082
Product	Strength	Form · route	Labeler	Product NDC
Austedodeutetrabenazine	Deutetrabenazine 9 mg/1	Tablet, CoatedOral	Teva Neuroscience, Inc.	68546-171
Austedodeutetrabenazine	Deutetrabenazine 12 mg/1	Tablet, CoatedOral	Teva Neuroscience, Inc.	68546-172
Austedodeutetrabenazine	—	Kit	Teva Neuroscience, Inc.	68546-176