Mekinist trametinib 0.5 mg Tablet, Film Coated, 30-count
by Novartis Pharmaceuticals Corporation · 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15)
NDC 00078-0666-15
🏷️ FDA NDC (as labeled)
0078-0666-15
billing pads the labeler segment with a zero
Rx only
Brand
On market
Non-controlled
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0078-0666-15
Product NDC
0078-0666
11-digit billing NDC
00078066615
NCPDP billing unit
EA — each (per item)
Application #
NDA204114
Mechanism of action
Kinase Inhibitor [EPC], Protein Kinase Inhibitors
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
TRAMETINIB DIMETHYL SULFOXIDE
GCN Seq No
071036
GCN
34726
HICL code
040361
Ingredient (HICL)
Trametinib Dimethyl Sulfoxide
HIC1 code
V
Therapeutic class — broad (HIC1)
Neoplasms
HIC2 code
V3
Therapeutic class — intermediate (HIC2)
Antineoplastic Drugs (Continued 1)
HIC3 code
V3U
Therapeutic class — specific (HIC3)
Antineoplastic - Mek Kinase Inhibitors
AHFS code
10:00.00.00
AHFS class
Antineoplastic Agents
FDB label name
MEKINIST 0.5 MG TABLET
FDB brand name
Mekinist
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 0078-0666-15 — a 4-4-2 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 labeler segment → 00078-0666-15. 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.
🏭 Manufacturer & labeler
LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA204114 (NDA)
Labeler code00078
Product typeHuman Prescription Drug
Portfolio209 products on file
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.
🩺 Clinical
Label name MEKINIST 0.5 MG TABLET Ingredient Trametinib Dimethyl Sulfoxide
📗 Our plain-language guide HelloPharmacist
- Trametinib works by blocking a specific mutated protein called BRAF V600E or V600K. If your tumor doesn't carry that mutation, the drug has no target to act on — so it simply won't...
- Why do I need a genetic test before starting this medicine?
- Yes, it really does matter. If you're taking the Mekinist tablet, you need to take it on an empty stomach — at least an hour before eating or two hours after a meal. A high-fat mea...
- Does it matter when I take it or whether I eat first?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Trametinib — 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.
💬 Questions about trametinib?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.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.
💲 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.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mekinist 0.5 mgthis 00078-0666-15 | Novartis | 30 tablets | — | — | FDA listed | — |
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.
⏳ Availability & generic status
🏛️
2013
First FDA approval
May 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2034
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 Feb 2034. 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.
Patents & exclusivity — FDA Orange Book
US 8952018 — method of use (U-2020)
US 8703781 — drug substance (U-2305)
US 8703781 — drug substance (U-2302)
US 8703781 — drug substance (U-2037)
US 8703781 — drug substance (U-2037)
US 8703781 — drug substance (U-1712)
US 8703781 — drug substance (U-2020)
US 8703781 — drug substance (U-1712)
US 8703781 — drug substance (U-2305)
US 8703781 — drug substance (U-2020)
US 8703781 — drug substance (U-2305)
US 8703781 — drug substance (U-1712)
US 8952018 — method of use (U-2020)
US 10869869 — method of use (U-3184)
US 10869869 — method of use (U-3184)
US 10869869 — method of use (U-3184)
US 8952018 — method of use (U-2020)
US 8703781 — drug substance (U-2302)
US 8703781 — drug substance (U-2020)
US 8703781 — drug substance (U-2037)
US 8703781 — drug substance (U-2302)
US 8580304 — drug product
US 9271941 — drug product
US 7378423 — drug substance
US 7378423 — drug substance
US 8580304 — drug product
US 9399021 — drug product
US 9155706 — drug product
US 9271941 — drug product
US 9399021 — drug product
US 9155706 — drug product
US 7378423 — drug substance
US 9399021 — drug product
US 8580304 — drug product
US 9155706 — drug product
US 9271941 — drug product
US 7378423*PED — drug product
US 7378423*PED — drug product
US 7378423*PED — drug product
US 8580304*PED — drug product
US 8580304*PED — drug product
US 8580304*PED — drug product
US 9155706*PED — drug product
US 9155706*PED — drug product
US 8952018*PED — drug product
US 8952018*PED — drug product
US 8952018*PED — drug product
US 9271941*PED — drug product
US 9155706*PED — drug product
US 9271941*PED — drug product
US 9271941*PED — drug product
US 8703781*PED — drug product
US 8703781*PED — drug product
US 8703781*PED — drug product
US 10869869*PED — drug product
US 10869869*PED — drug product
US 10869869*PED — drug product
US 9399021*PED — drug product
US 9399021*PED — drug product
US 9399021*PED — drug product
Exclusivity I-908
Exclusivity ODE-428
Exclusivity I-908
Exclusivity ODE-428
Exclusivity I-908
Exclusivity ODE-428
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2013
2015
2017
2019
2021
2023
2025
2027
2029
2031
2033
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 (60)
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8952018 ↗ | Method of use | U-2020 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2305 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2302 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2037 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2037 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-1712 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2020 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-1712 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2305 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2020 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2305 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-1712 | Oct 15, 2030 |
| US 8952018 ↗ | Method of use | U-2020 | Oct 15, 2030 |
| US 10869869 ↗ | Method of use | U-3184 | Aug 30, 2033 |
| US 10869869 ↗ | Method of use | U-3184 | Aug 30, 2033 |
| US 10869869 ↗ | Method of use | U-3184 | Aug 30, 2033 |
| US 8952018 ↗ | Method of use | U-2020 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2302 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2020 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2037 | Oct 15, 2030 |
| US 8703781 ↗ | Drug substance | U-2302 | Oct 15, 2030 |
| US 8580304 ↗ | Drug product | — | Jan 28, 2032 |
| US 9271941 ↗ | Drug product | — | Jan 28, 2032 |
| US 7378423 ↗ | Drug substance | — | May 29, 2027 |
| US 7378423 ↗ | Drug substance | — | May 29, 2027 |
| US 8580304 ↗ | Drug product | — | Jan 28, 2032 |
| US 9399021 ↗ | Drug product | — | Jan 28, 2032 |
| US 9155706 ↗ | Drug product | — | Jan 28, 2032 |
| US 9271941 ↗ | Drug product | — | Jan 28, 2032 |
| US 9399021 ↗ | Drug product | — | Jan 28, 2032 |
| US 9155706 ↗ | Drug product | — | Jan 28, 2032 |
| US 7378423 ↗ | Drug substance | — | May 29, 2027 |
| US 9399021 ↗ | Drug product | — | Jan 28, 2032 |
| US 8580304 ↗ | Drug product | — | Jan 28, 2032 |
| US 9155706 ↗ | Drug product | — | Jan 28, 2032 |
| US 9271941 ↗ | Drug product | — | Jan 28, 2032 |
| US 7378423*PED ↗ | Drug product | — | Nov 29, 2027 |
| US 7378423*PED ↗ | Drug product | — | Nov 29, 2027 |
| US 7378423*PED ↗ | Drug product | — | Nov 29, 2027 |
| US 8580304*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 8580304*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 8580304*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9155706*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9155706*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 8952018*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 8952018*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 8952018*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 9271941*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9155706*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9271941*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9271941*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 8703781*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 8703781*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 8703781*PED ↗ | Drug product | — | Apr 15, 2031 |
| US 10869869*PED ↗ | Drug product | — | Feb 28, 2034 |
| US 10869869*PED ↗ | Drug product | — | Feb 28, 2034 |
| US 10869869*PED ↗ | Drug product | — | Feb 28, 2034 |
| US 9399021*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9399021*PED ↗ | Drug product | — | Jul 28, 2032 |
| US 9399021*PED ↗ | Drug product | — | Jul 28, 2032 |
FDA exclusivity
| Code | What it grants | Expires |
|---|---|---|
| I-908 | New indication (3-year) | Mar 16, 2026 |
| ODE-428 | Orphan Drug Exclusivity (7-year) | Mar 16, 2030 |
| I-908 | New indication (3-year) | Mar 16, 2026 |
| ODE-428 | Orphan Drug Exclusivity (7-year) | Mar 16, 2030 |
| I-908 | New indication (3-year) | Mar 16, 2026 |
| ODE-428 | Orphan Drug Exclusivity (7-year) | Mar 16, 2030 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2026 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2026 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2026 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2030 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2030 |
| PED | Pediatric Exclusivity (+6 months) | Sep 16, 2030 |
Common questions
Is there a generic version of MEKINIST 0.5 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for MEKINIST 0.5 MG TABLET. See the alternatives section for substitutable, lower-cost products.
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Mekinist — 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 Mekinist. 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
$81.4M
Claims incl. refills
5.2K
Beneficiaries
2.2K
Spend / beneficiary
$36,211.30
Spend / claim
$15,714.86
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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mekinist (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 51%
Female · 49%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00078-0666-15 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15) | 2016-03-17 | Active |
🧭 About this NDC listing & data coverage
Finished prescription product
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 No photo available yet for this listing. |
| 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.
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 FDA registers it as 0078-0666-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00078-0666-15, written without dashes as 00078066615. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00078-0666-15, the first segment (00078) is the labeler code FDA assigned to Novartis Pharmaceuticals Corporation; the middle segment (0666) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Novartis Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novartis Pharmaceuticals Corporation 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.
📄 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.
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.