Prescription drug · NDA
Austedo (Deutetrabenazine) NDC 68546-176
Kit · Teva Neuroscience, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68546-176-28 | 68546017628 | 1 BLISTER PACK in 1 CARTON (68546-176-28) / 1 KIT in 1 BLISTER PACKMarketed from Feb 1, 2020 · Sample package |
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
- Dosage form
- Kit
- Labeler
- Teva Neuroscience, Inc.NDC labeler code 68546
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208082
- Marketing start
- Listing expires
- Identifiers
- Product ID 68546-176_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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N468546017628followed by a unit qualifier and the quantityPackage 68546-0176-28. 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 68546-176
- What is NDC 68546-176?
- 68546-176 is the product NDC for Austedo (deutetrabenazine) kit, 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 (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?
- 3 other product NDCs are listed under this name. See all Austedo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Austedo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Austedodeutetrabenazine | Deutetrabenazine 6 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-170 | 68546-0170-60 |
| Austedodeutetrabenazine | Deutetrabenazine 9 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-171 | 68546-0171-60 |
| Austedodeutetrabenazine | Deutetrabenazine 12 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-172 | 68546-0172-60 |
Other NDCs under NDA 208082
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 |
|---|---|---|---|---|
| Austedodeutetrabenazine | Deutetrabenazine 6 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-170 |
| Austedodeutetrabenazine | Deutetrabenazine 9 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-171 |
| Austedodeutetrabenazine | Deutetrabenazine 12 mg/1 | Tablet, CoatedOral | Teva Neuroscience, Inc. | 68546-172 |