Prescription drug · NDA
Austedo XR (Deutetrabenazine) NDC 68546-471
Deutetrabenazine 12 mg/1 · Tablet, Film coated, Extended release · Oral · Teva Neuroscience, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68546-471-56 | 68546047156 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-471-56)Marketed from Feb 21, 2023 |
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 XR
- Generic name (nonproprietary)
- deutetrabenazine
- Active ingredients
- Deutetrabenazine — 12 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Teva Neuroscience, Inc.NDC labeler code 68546
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216354
- Marketing start
- Listing expires
- Identifiers
- Product ID 68546-471_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
N468546047156followed by a unit qualifier and the quantityPackage 68546-0471-56. 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 . 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.
About NDC 68546-471
- What is NDC 68546-471?
- 68546-471 is the product NDC for Austedo XR (deutetrabenazine), Deutetrabenazine 12 mg/1 tablet, film coated, extended release, listed with the FDA by Teva Neuroscience, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Austedo XR (Deutetrabenazine).
- What is the active ingredient?
- Deutetrabenazine.
- Who is the labeler?
- Teva Neuroscience, Inc., NDC labeler code 68546. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Austedo XR?
- 8 other product NDCs are listed under this name. See all Austedo XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Austedo XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Austedo XRdeutetrabenazine | — | Kit | Teva Neuroscience, Inc. | 68546-477 | 68546-0477-2868546-0477-29 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 18 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-479 | 68546-0479-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 48 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-476 | 68546-0476-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-473 | 68546-0473-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 36 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-474 | 68546-0474-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 42 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-475 | 68546-0475-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 24 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-472 | 68546-0472-56 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 6 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-470 | 68546-0470-56 |
Other NDCs under NDA 216354
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Austedo XRdeutetrabenazine | Deutetrabenazine 24 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-472 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 6 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-470 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 48 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-476 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-473 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 36 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-474 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 42 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-475 |
| Austedo XRdeutetrabenazine | — | Kit | Teva Neuroscience, Inc. | 68546-477 |
| Austedo XRdeutetrabenazine | Deutetrabenazine 18 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Neuroscience, Inc. | 68546-479 |