AUSTEDO deutetrabenazine Kit — NDC 68546-182-70 (Billing 68546-0182-70)
by Teva Neuroscience, Inc. · 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
This is a package of AUSTEDO deutetrabenazine Kit from Teva Neuroscience, Inc., no longer marketed, no longer in the FDA NDC Directory.
NDC 68546-0182-70
🏷️ FDA NDC (as labeled)
68546-182-70
billing pads the product segment with a zero
This package
Contains1 kit in 1 blister pack
Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 68546-182-70 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68546 labeler · 182 product · 70 package
- Barcode (UPC-A, from the NDC)
- 3 6854618270 4
- FDA record last changed
- Mar 13, 2024
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
68546-182-70
Product NDC
68546-182
11-digit billing NDC
68546018270
NCPDP billing unit
EA — each (per item)
Application #
NDA208082
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Feb 2024)
Dosage form
KIT
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
083499
GCN
52483
HICL code
044192
Ingredient (HICL)
Deutetrabenazine
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H6
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On The Midbrain
HIC3 code
H6L
Therapeutic class — specific (HIC3)
Drugs To Treat Movement Disorders
AHFS code
28:56.00.00
AHFS class
Vesicular Monoamine Transport2 Inhibitor
FDB label name
AUSTEDO 12MG START TITR(WK1-4)
FDB brand name
Austedo 12Mg Start Titr(Wk1-4)
Legend status
F — Federal legend — prescription drug or device
Quick answers
- GSN (GCN sequence number): 083499
- GCN: 52483
- HICL (First Databank): 044192
- AHFS class code: 28:56.00.00
Why two NDCs?
The FDA registers this code as 68546-182-70 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68546-0182-70. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name AUSTEDO 12MG START TITR(WK1-4) Ingredient Deutetrabenazine
📗 Our plain-language guide HelloPharmacist
- It treats involuntary movements in adults. That means chorea from Huntington’s disease and tardive dyskinesia. Both Austedo and Austedo XR are approved for these.
- Swallow the tablet whole, without chewing, crushing or breaking it. Austedo XR is taken once a day, with or without food. Austedo is taken with food, and at higher total daily dose...
- The most common ones are sleepiness, fatigue, diarrhea and dry mouth. Some people also have trouble sleeping or catch more colds. Don’t drive until you know how it affects you.
- Call about any new or worse depression, suicidal thoughts, or unusual behavior changes. Also call if you feel very restless, have stiffness, slowed movement, or falls, or if you ge...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Deutetrabenazine — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about deutetrabenazine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
1 kit
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68546-0182-49 68546-182-49 Main listing | 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2021-05-06 | — | Active |
| 68546-0182-70 You're viewing this | 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2021-05-06 | — | Discontinued by firm |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 3 blister pack in 1 carton / 1 kit in 1 blister pack.
What NDC number is used to bill for this package of AUSTEDO deutetrabenazine Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Austedo Xr 68546-0477-28 | Teva | 7 tablets | $249.323 | — | Availability likely | — |
| Austedo 68546-0176-28 | Teva | 1 kit | — | — | FDA listed | — |
| Austedothis 68546-0182-70 | Teva | 1 kit | — | — | Discontinued | — |
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2017
First FDA approval
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
When could a generic Austedo arrive?
Our estimate: April 2033 about 6.5 years away
How sure: Likely. Firm enough to plan around, but a court ruling or a new deal could still move it.
Why then: The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
That is before the September 2038 date above, which is common: a court ruling or a deal with the brand’s maker often lets a generic in before the last patent runs out.
See the full forecast for generic Austedo →Patents & exclusivity — FDA Orange Book
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-1995)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-3055)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-3055)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11813232 — drug product
US 9233959 — drug product
US 8524733 — drug substance
US 9814708 — drug product
US 9296739 — drug product
US 9296739 — drug product
US 9233959 — drug product
US 11813232 — drug product
US 11666566 — drug product
US 9296739 — drug product
US 11813232 — drug product
US 8524733 — drug substance
US 11666566 — drug product
US 9233959 — drug product
US 11666566 — drug product
US 8524733 — drug substance
US 9814708 — drug product
US 9814708 — drug product
US 9233959*PED — drug product
US 9233959*PED — drug product
US 8524733*PED — drug product
US 8524733*PED — drug product
US 9233959*PED — drug product
US 8524733*PED — drug product
US 9296739*PED — drug product
US 9550780*PED — drug product
US 9550780*PED — drug product
US 9296739*PED — drug product
US 9296739*PED — drug product
US 9550780*PED — drug product
US 9814708*PED — drug product
US 9814708*PED — drug product
US 9814708*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11666566*PED — drug product
US 11666566*PED — drug product
US 11666566*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
2017
2019
2021
2023
2025
2027
2029
2031
2033
2035
2037
Substance patent
Formulation patent
Method-of-use patent
Exclusivity
Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
Listed patents (96)
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9550780 ↗ | Drug substance | U-1995 | Sep 18, 2033 |
| US 9550780 ↗ | Drug substance | U-1995 | Sep 18, 2033 |
| US 9550780 ↗ | Drug substance | U-1995 | Sep 18, 2033 |
| US 10959996 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 10959996 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 10959996 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 11564917 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11564917 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11564917 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 11357772 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 12016858 ↗ | Method of use | U-3055 | Mar 7, 2036 |
| US 11648244 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11648244 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11648244 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 9550780 ↗ | Drug substance | U-3055 | Sep 18, 2033 |
| US 9550780 ↗ | Drug substance | U-3055 | Sep 18, 2033 |
| US 9550780 ↗ | Drug substance | U-3055 | Sep 18, 2033 |
| US 11179386 ↗ | Method of use | U-1995 | Mar 15, 2038 |
| US 11179386 ↗ | Method of use | U-1995 | Mar 15, 2038 |
| US 11179386 ↗ | Method of use | U-1995 | Mar 15, 2038 |
| US 11179386 ↗ | Method of use | U-3055 | Mar 15, 2038 |
| US 11179386 ↗ | Method of use | U-3055 | Mar 15, 2038 |
| US 11179386 ↗ | Method of use | U-3055 | Mar 15, 2038 |
| US 11446291 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11446291 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11446291 ↗ | Method of use | U-1995 | Mar 7, 2036 |
| US 11813232 ↗ | Drug product | — | Mar 15, 2038 |
| US 9233959 ↗ | Drug product | — | Sep 18, 2033 |
| US 8524733 ↗ | Drug substance | — | Apr 3, 2031 |
| US 9814708 ↗ | Drug product | — | Sep 18, 2033 |
| US 9296739 ↗ | Drug product | — | Sep 18, 2033 |
| US 9296739 ↗ | Drug product | — | Sep 18, 2033 |
| US 9233959 ↗ | Drug product | — | Sep 18, 2033 |
| US 11813232 ↗ | Drug product | — | Mar 15, 2038 |
| US 11666566 ↗ | Drug product | — | Sep 18, 2033 |
| US 9296739 ↗ | Drug product | — | Sep 18, 2033 |
| US 11813232 ↗ | Drug product | — | Mar 15, 2038 |
| US 8524733 ↗ | Drug substance | — | Apr 3, 2031 |
| US 11666566 ↗ | Drug product | — | Sep 18, 2033 |
| US 9233959 ↗ | Drug product | — | Sep 18, 2033 |
| US 11666566 ↗ | Drug product | — | Sep 18, 2033 |
| US 8524733 ↗ | Drug substance | — | Apr 3, 2031 |
| US 9814708 ↗ | Drug product | — | Sep 18, 2033 |
| US 9814708 ↗ | Drug product | — | Sep 18, 2033 |
| US 9233959*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9233959*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 8524733*PED ↗ | Drug product | — | Oct 3, 2031 |
| US 8524733*PED ↗ | Drug product | — | Oct 3, 2031 |
| US 9233959*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 8524733*PED ↗ | Drug product | — | Oct 3, 2031 |
| US 9296739*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9550780*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9550780*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9296739*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9296739*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9550780*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9814708*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9814708*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 9814708*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 11813232*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 11813232*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 11813232*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 10959996*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 10959996*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 10959996*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11564917*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11564917*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11564917*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11179386*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 11179386*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 11179386*PED ↗ | Drug product | — | Sep 15, 2038 |
| US 11666566*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 11666566*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 11666566*PED ↗ | Drug product | — | Mar 18, 2034 |
| US 11648244*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11648244*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11648244*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11446291*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11446291*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11446291*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11357772*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11357772*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 11357772*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 12016858*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 12016858*PED ↗ | Drug product | — | Sep 7, 2036 |
| US 12016858*PED ↗ | Drug product | — | Sep 7, 2036 |
Common questions
Is there a generic version of AUSTEDO 12MG START TITR(WK1-4)?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for AUSTEDO 12MG START TITR(WK1-4). See the alternatives section for substitutable, lower-cost products. An approval does not always mean it is on pharmacy shelves yet: we expect the first generic Austedo in April 2033, about 6.5 years away. See the forecast.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
- FDA Orange Book · refreshed Oct 9, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Deutetrabenazine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
Manufacturer & labeler
LabelerTeva Neuroscience, Inc.
Application holderTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC
FDA applicationNDA208082 (NDA)
Labeler code68546
Product typeHuman Prescription Drug
Portfolio17 products on file
More NDCs from Teva Neuroscience, Inc. labeler code 68546
- Azilect Rasagiline mesylate .5 mg Tablet NDC 68546-142-56
- Austedo Deutetrabenazine 6 mg Tablet, Coated NDC 68546-170-60
- Austedo Deutetrabenazine 9 mg Tablet, Coated NDC 68546-171-60
- Austedo Deutetrabenazine 12 mg Tablet, Coated NDC 68546-172-60
- AUSTEDO deutetrabenazine Kit NDC 68546-176-28
- Azilect Rasagiline mesylate 1 mg Tablet NDC 68546-229-56
- Copaxone Glatiramer Acetate 20 mg/mL Injection, Solution NDC 68546-317-30
- Copaxone Glatiramer Acetate 40 mg/mL Injection, Solution NDC 68546-325-06
- Austedo XR deutetrabenazine 6 mg Tablet, Film Coated, Extended Release NDC 68546-470-56
- Austedo XR deutetrabenazine 12 mg Tablet, Film Coated, Extended Release NDC 68546-471-56
- Austedo XR deutetrabenazine 24 mg Tablet, Film Coated, Extended Release NDC 68546-472-56
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Austedo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Austedo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$242.57M
Claims incl. refills
35.1K
Beneficiaries
11.7K
Spend / beneficiary
$20,711.19
Spend / claim
$6,904.32
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
About this NDC listing & data coverage
Finished prescription product
Kit / multi-component package
No longer marketed (per FDA listing data)
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC The FDA label for this product carries no photos. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (68546-0182-49). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Neuroscience, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.