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LEVULAN KERASTICK aminolevulinic acid hydrochloride Kit — NDC 67308-0101-06 package photo

LEVULAN KERASTICK aminolevulinic acid hydrochloride Kit

by Sun Pharmaceutical Industries, Inc · 6 APPLICATOR in 1 CARTON (67308-101-06) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
NDC 67308-0101-06
🏷️ FDA NDC (as labeled) 67308-101-06 billing pads the product segment with a zero
This package
Contains1 kit in 1 applicator * 1.5 mL in 1 ampule * 1.5 mL in 1 ampule Medicaid pays$312.05 / unit · 12 mo Pack sizes3 compare ↓
Also comes in: 1 kit 67308-0101-01 2 applicators 67308-0101-02
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 67308-101-06
Product NDC 67308-101
11-digit billing NDC 67308010106
NCPDP billing unit EA — each (per item)
RxCUI 762672, 762674
Application # NDA020965
SPL Set ID e45cc371-9ebc-4904-12bc-65cb4e2817ad
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-09-04
Dosage form KIT
GPI-14 90375015102120
GPI class Levulan Kerastick
GCN Seq No 047723
GCN 12698
HICL code 021920
Ingredient (HICL) Aminolevulinic Acid Hcl
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5J
Therapeutic class — specific (HIC3) Photoact,Topical Antineoplast,Premalignant Lesions
AHFS code 84:18.00.00
AHFS class Antiproliferants
FDB label name LEVULAN KERASTICK 20%
FDB brand name Levulan
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 67308-101-06 — 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 → 67308-0101-06. 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

LabelerSun Pharmaceutical Industries, Inc
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationNDA020965 (NDA)
Labeler code67308
First marketedSep 2000
Product typeHuman Prescription Drug
Portfolio9 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 LEVULAN KERASTICK 20% Ingredient Aminolevulinic Acid Hcl
📖 What it is MedlinePlus · NLM

Aminolevulinic acid is used with light therapy to treat actinic keratoses (small crusty or scaly patches of skin formed by exposure to sunlight; can turn into cancer if not treated) of the face,scalp, or upper arms. Aminolevulinic acid is in a class of medications called photosensitizing agents. Photosensitizing agents combined with light therapy is called phytodynamic therapy (PDT). The light activates the drug which then kills abnormal cells.

Read the full MedlinePlus article ↗
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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $312.05 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7308 $389.280 / J7308 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)67308-101-06
11-digit billing NDC67308-0101-06
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7308
DescriptorAminolevulinic acid hcl for topical administration, 20%, single unit dosage form (354 mg)
Billing units / pkg6 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levulan Kerastickthis 67308-0101-06 Sun 6 applicators — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
1999
First FDA approval
Dec 1999
📍
2026
Currently FDA-listed
27 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 3, 1999 RLD RS ⏳ ~11.3 yr to latest listed protection

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 11690914 — method of use (U-3163)
US 11077192 — method of use (U-3163)
US 12290700 — method of use (U-804)
US 11697028 — method of use (U-804)
US 11446512 — method of use (U-804)
US 11179574 — method of use (U-804)
US 12296011 — method of use (U-3163)
US 10357567 — method of use (U-3163)
US 11571478 — method of use (U-3163)
US 11135293 — method of use (U-3163)
1999 2001 2003 2005 2007 2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037
Today
LOE
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 (10)
PatentTypeUse codeExpires
US 11690914 ↗ Method of use U-3163 Jan 12, 2038
US 11077192 ↗ Method of use U-3163 Jan 12, 2038
US 12290700 ↗ Method of use U-804 Oct 13, 2036
US 11697028 ↗ Method of use U-804 Oct 13, 2036
US 11446512 ↗ Method of use U-804 Jan 17, 2037
US 11179574 ↗ Method of use U-804 Oct 13, 2036
US 12296011 ↗ Method of use U-3163 Jan 12, 2038
US 10357567 ↗ Method of use U-3163 Jan 12, 2038
US 11571478 ↗ Method of use U-3163 Jan 12, 2038
US 11135293 ↗ Method of use U-3163 Jan 12, 2038
Common questions
Is there a generic version of LEVULAN KERASTICK 20%?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LEVULAN KERASTICK 20%. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2038 — an estimate, not a guaranteed launch date.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 67308-0101-06, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
495
Units reimbursed last 4 qtrs
560
Gross reimbursed last 4 qtrs
$174.7K
Avg / prescription
$353.03
Avg / unit
$312.05
Latest quarter Q1 2026
120Rx
Fee-for-service vs managed care ⓘ
21% FFS 79% MCO
Fee-for-service · 106 Rx Managed care · 389 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 33 units · 0.6 per 100k residents MN Wisconsin: 35 units · 0.6 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 33 units · 0.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 41 units · 0.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 26 units · 0.4 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 60 units · 0.7 per 100k residents VA Maryland: no data reported MD Connecticut: 43 units · 1.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 158 units · 2.1 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 13 units · 0.3 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 118 units · 0.5 per 100k residents FL
Units reimbursed · per 100k residents
0.32.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 2.1 /100k
2 Connecticut 1.2 /100k
3 Oregon 0.8 /100k
4 Virginia 0.7 /100k
5 Indiana 0.6 /100k
6 Wisconsin 0.6 /100k
7 Minnesota 0.6 /100k
8 Florida 0.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 kit67308-0101-01 572 Rx · $300,402
6 applicators this page67308-0101-06 495 Rx · $174,748
2 applicators67308-0101-02 No Medicaid data
Drug total (last 4 qtrs): 1,067 Rx · 1,211 units · $475,151 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 LEVULAN KERASTICK (this brand).

Top reported reactions

Poor Quality Product Administered177
Product Quality Issue153
Erythema102
Pain63
Product Physical Issue62
Blister48
Application Site Pain42

Age at onset

Neonate1
Child4
Adolescent5
Adult105
Elderly135

Reporter sex

1,430 reports
Male · 44%
Female · 56%

Serious outcomes

Life-threatening12
Disabling9
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 212 0
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 NDCDescription Marketing startStatus
67308-0101-01 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE 2000-09-04 Active
67308-0101-02 2 APPLICATOR in 1 CARTON (67308-101-02) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE 2000-12-20 Active
67308-0101-06 You're viewing this 6 APPLICATOR in 1 CARTON (67308-101-06) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE 2000-09-24 Active

This pack accounts for about 46% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 67308-0101-06?
NDC 67308-0101-06 is listed by the FDA — 6 applicator in 1 carton / 1 kit in 1 applicator * 1.5 ml in 1 ampule * 1.5 ml in 1 ampule.
What NDC number is used to bill for this package of LEVULAN KERASTICK aminolevulinic acid hydrochloride Kit?
Bill NDC 67308-0101-06 — the 11-digit billing format is 67308010106. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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) ✓ Available
Package photos ✓ Available
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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.
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 67308-101-06, 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: 67308-0101-06, written without dashes as 67308010106. 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 67308-0101-06, the first segment (67308) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 Sun Pharmaceutical Industries, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 kit (67308-0101-01), 2 applicators (67308-0101-02). 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?
Sun Pharmaceutical Industries, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7308 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 89 words ▾

1 INDICATIONS AND USAGE The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.( 2.1 ) Apply the drug product to the target lesions. ( 2.1 ) Illuminate with blue light using the BLU-U ® Blue Light Photodynamic Therapy Illuminator after the incubation time of( 2.2 ): 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks ( 2.1 ) For topical use only.

( 2.1) See full prescribing information for complete dosage and administration instruction. ( 2 ) See BLU-U user manual for detailed lamp safety and operating instructions. ( 2.2 )

2.1Preparation and Administration Overview After mixing, the LEVULAN KERASTICK topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel. Application should involve lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient. LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.

TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1 The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp. 2 The incubation time is 3 hours for actinic keratosis lesions on the upper extremities. LEVULAN KERASTICK topical solution application Time window 1 for Blue Light Illumination for face or scalp Time window 2 for Blue Light Illumination for upper extremities 6 am 8 pm to Midnight 9 am 7 am 9 pm to 1 am 10 am 8 am 10 pm to 2 am 11 am 9 am 11 pm to 3 am 12 Noon 10 am Midnight to 4 am 1 pm 11 am 1 am to 5 am 2 pm 12 pm 2 am to 6 am 3 pm 1 pm 3 am to 7 am 4 pm 2 pm 4 am to 8 am 5 pm 3 pm 5 am to 9 am 6 pm 4 pm 6 am to 10 am 7 pm 5 pm 7 am to 11 am 8 pm 6 pm 8 am to Noon 9 pm 7 pm 9 am to 1 pm 10 pm 8 pm 10 am to 2 pm 11 pm 9 pm 11 am to 3 pm 12 Midnight 10 pm Noon to 4 pm 1 am If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, he or she may nonetheless experience sensations of stinging and/or burning if the photosensitized actinic keratoses are exposed to sunlight or prolonged or intense light at that time.

Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced. LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment.

2.2Dosage and Administration Instructions Step A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical Solution Preparation of Lesions Actinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution. Preparation of LEVULAN KERASTICK topical solution The LEVULAN KERASTICK applicator consists of a plastic tube containin…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device. Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight. After mixture, topical solution contains 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device. ( 3 )

⛔ Contraindications 93 words ▾

4 CONTRAINDICATIONS The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Cutaneous photosensitivity at wavelengths of 400-450 nm [see Warnings and Precautions (5.2) ] Porphyria or known allergies to porphyrins [see Warnings and Precautions (5.2) ] Known sensitivity to any of the components of the LEVULAN KERASTICK. Cutaneous photosensitivity at wavelengths of 400-450 nm. ( 4 ) Porphyria or known allergies to porphyrins.

( 4 ) Sensitivity to any of the components of the LEVULAN KERASTICK. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

( 5.1 ) Avoid exposure of the photosensitive actinic keratoses to sunlight or bright indoor light prior to blue light treatment. Protect treated lesions from sunlight exposure. Sunscreens will not protect the patient against photosensitivity reactions.

( 5.2 ) The LEVULAN KERASTICK for topical solution should be used by a qualified health professional. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion. ( 5.2 ) Irritation may be experienced if this product is applied to eyes or mucous membranes.

Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours. ( 5.3 )

5.1Transient Amnestic Episodes Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

5.2Photosensitivity After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves.

Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin. Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization.

Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions.

If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced.

5.3Irritation The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

5.4 Coagulation Defects The…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes [see Warnings and Precautions (5.1) ] Increased Photosensitivity [see Warnings and Precautions (5.2) ] Irritation [see Warnings and Precautions (5.3) ] Coagulation defects [see Warnings and Precautions (5.4) ] The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Dermatology at 877-533-3872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy. Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials for actinic keratoses treatment.

Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning. Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator.

The most common local adverse reactions (incidence ≥ 10%) were application site stinging/burning, erythema, edema, scaling/crusting, hypo/hyperpigmentation, itching, erosion, oozing/vesiculation/crusting, dryness. In the trials for face and scalp lesions, severe stinging and/or burning at one or more lesions during light treatment was reported by at least 50% of subjects. Severe stinging and/or burning also occurred during light treatment in 9% of subjects receiving treatment for upper extremity lesions.

The majority of subjects reported that all lesions treated exhibited at least slight stinging and/or burning. In trials of the face and scalp, the sensation of stinging/burning appeared to reach a plateau at 6 minutes into the treatment. Less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning.

No subjects discontinued light treatment in the trial for upper extremity lesions. In trials for the face or scalp lesions, 99% of the active treatment group and 79% of the vehicle group experienced erythema shortly after treatment. In the trial for the upper extremity lesions, 99% of LEVULAN KERASTICK topical solution treatment group and 52% of the vehicle group experienced erythema on visit Days 2-3.

Approximately 35% of LEVULAN KERASTICK topical solution group had edema, while edema occurred in < 1% of the vehicle group. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy for face or scalp. Edema resolved by 4 weeks and erythema resolved to baseline by 8 weeks for upper extremities.

The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses [see Warnings and Precautions (5.2) ] . Other Localized Cutaneous Adverse Experiences: Table 2 depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp. TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Sca…

🔄 Drug Interactions 108 words ▾

7 DRUG INTERACTIONS There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK topical solution [see Warnings and Precautions (5.2) ] .

Concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3) ].

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of LEVULAN KERASTICK topical solution in either human or animal milk, the effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEVULAN KERASTICK topical solution and any potential adverse effects on the breastfeeding child from LEVULAN KERASTICK topical solution or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population.

8.5Geriatric Use Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over. No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 126 words ▾

8.1Pregnancy Risk Summary Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3) ].

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 31 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population.

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over. No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 79 words ▾

10 OVERDOSAGE

10.1LEVULAN KERASTICK Topical Solution Overdose In the event that the drug is ingested, monitoring and supportive care are recommended. The patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours after ingestion. The consequences of exceeding the recommended topical dosage are unknown.

10.2BLU-U Light Overdose There is no information on overdose of blue light from the BLU-U Blue Light Photodynamic Therapy Illuminator following LEVULAN KERASTICK topical solution application.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.

LEVULAN KERASTICK Photodynamic Therapy of actinic keratoses is the combination of photosensitization by application of the LEVULAN KERASTICK topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.

12.2Pharmacodynamics ALA does not exhibit fluorescence, while PpIX has a high fluorescence yield. Time-dependent changes in surface fluorescence have been used to determine PpIX accumulation and clearance in actinic keratoses and perilesional skin after application of the LEVULAN KERASTICK topical solution in 12 subjects. Peak fluorescence intensity was reached in 11 ± 1 hr in actinic keratoses and 12 ± 1 hr in perilesional skin.

The mean clearance half-life of fluorescence for lesions was 30 ± 10 hr and 28 ± 6 hr for perilesional skin. The fluorescence in perilesional skin was similar to that in actinic keratoses. Therefore, the LEVULAN KERASTICK topical solution should only be applied to the affected skin.

12.3Pharmacokinetics Two human pharmacokinetic (PK) studies were conducted in subjects with minimally to moderately thick actinic keratoses on the upper extremities, having at least 6 lesions on one upper extremity and at least 12 lesions on the other upper extremity. A single dose comprising of two topical applications of LEVULAN KERASTICK topical solution (each containing 354 mg ALA HCl) were directly applied to the lesions and occluded for 3 hours prior to light treatment. The first PK study was conducted in 29 subjects and PK parameters of ALA were assessed.

The baseline-corrected mean ± SD of the maximum concentration (C max ) of ALA was 249.9 ± 694.5 ng/mL and the median time to reach C max (T max ) was 2 hr post dose. The mean ± SD exposure to ALA, as expressed by area under the concentration time curve (AUC t ) was 669.9 ± 1610 ng∙hr/mL. The mean ± SD elimination half-life (T 1/2 ) of ALA was 5.7 ± 3.9 hr.

A second PK study was conducted in 14 subjects and PK parameters of ALA and PpIX were measured. The baseline-corrected PpIX concentrations were negative in at least 50% of samples in 50% (7/14) subjects and AUC could not be estimated reliably. The baseline-corrected mean ± SD of C max for ALA and PpIX was 95.6 ± 120.6 ng/mL and 0.95 ± 0.71 ng/mL, respectively.

The median T max of ALA and PpIX was 2 hr post dose and 12 hr post dose, respectively. The mean AUC t of ALA was 261.1 ± 229.3 ng∙hr/mL. The mean ± SD T 1/2 of ALA was 8.5 ± 6.7 hr.

🧬 Mechanism of Action 129 words ▾

12.1Mechanism of Action Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.

LEVULAN KERASTICK Photodynamic Therapy of actinic keratoses is the combination of photosensitization by application of the LEVULAN KERASTICK topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.

📦 How Supplied / Storage and Handling 163 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied The LEVULAN KERASTICK for topical solution, 20%, is supplied in packs of 6 applicators. Each LEVULAN KERASTICK applicator is for single use and consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains 354 mg of aminolevulinic acid HCl. The applicator is covered with a protective cardboard sleeve and cap.

16.2Product Package - NDC Number Carton of 6 LEVULAN KERASTICK for topical solution, 20% applicators 67308-101-06

16.3Storage Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F) [See USP Controlled Room Temperature]. The LEVULAN KERASTICK topical solution should be used immediately following preparation (dissolution). Solution application must be completed within 2 hours of preparation. An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new LEVULAN KERASTICK applicator used, if needed.

📋 Description 217 words ▾

11 DESCRIPTION LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil. The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59).

The structural formula is represented below: The LEVULAN KERASTICK for topical solution applicator is a two-component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of aminolevulinic acid HCl as a dry solid.

The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. “LEVULAN KERASTICK for topical solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK topical solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only. Levulan-04

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Transient Amnestic Episodes Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.1) ].

Photosensitivity Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.2) ]. Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours.

Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions [see Warnings and Precautions (5.2) ]. Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light.

It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin [see Warnings and Precautions (5.2) ]. If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours.

If stinging and/or burning is noted, exposure to light should be reduced [see Warnings and Precautions (5.2) ]. Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT [see Drug Interactions (7) ] . Common Adverse Reactions Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.

LEVULAN, KERASTICK, KERASTICK KRUSHER, BLU-U, and DUSA are registered trademarks of DUSA Pharmaceuticals, Inc., a Sun Pharma company © 2020 Sun Pharmaceutical Industries, Inc. All rights reserved. Manufactured by: Sun Pharmaceutical Industries, Inc.

Billerica, MA, 01821 LAB-0530AW, Revision: F Sun Pharmaceutical Industries, Inc. Princeton, NJ 1-877-533-3872 Levulan-09

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.