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Methoxsalen 10 mg Capsule, Liquid Filled, 50-count — NDC 64380-0752-16 package photo
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Methoxsalen 10 mg Capsule, Liquid Filled, 50-count — NDC 64380-752-16 (Billing 64380-0752-16)

by Strides Pharma Science Limited · 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS

This is a package of 50 capsules of Methoxsalen 10 mg Capsule, Liquid Filled from Strides Pharma Science Limited, marketed since Dec 2016 and currently FDA-listed. It is this product's only package size.

NDC 64380-0752-16
🏷️ FDA NDC (as labeled) 64380-752-16 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Past resolved recalls for this product (1)
Class II · Dec 29, 2023 · Terminated — Failed Dissolution Specifications (Strides Pharma Inc.) · FDA recall D-0260-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64380-752-16
Product NDC 64380-752
11-digit billing NDC 64380075216
NCPDP billing unit EA — each (per item)
RxCUI 1812434
UNII U4VJ29L7BQ
UPC 0364380752165
Application # ANDA202687
SPL Set ID a6ec8292-9189-4ebd-862a-e1725eb29eef
Established class (EPC) Photoactivated Radical Generator; Psoralen
Mechanism of action Photoabsorption
Physiologic effect Photosensitizing Activity
Chemical class Psoralens
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-12-08
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance METHOXSALEN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90250560100110
GCN Seq No 047874
GCN 13302
HICL code 002720
Ingredient (HICL) Methoxsalen
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L1
Therapeutic class — intermediate (HIC2) Drugs To Treat Specific Top Diseases (Systemic)
HIC3 code L1A
Therapeutic class — specific (HIC3) Antipsoriatic Agents,Systemic
AHFS code 84:50.06.00
AHFS class Pigmenting Agents
FDB label name METHOXSALEN 10 MG SOFTGEL
FDB brand name Methoxsalen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047874
  • GCN: 13302
  • GPI-14 (Medi-Span): 90250560100110
  • HICL (First Databank): 002720
  • AHFS class code: 84:50.06.00
  • RxCUI (RxNorm): 1812434
Why two NDCs? The FDA registers this code as 64380-752-16 — 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 → 64380-0752-16. 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.

RxNorm drug class

This medicine belongs to the Psoralen class.

Pharmacologic class Psoralen, Photoactivated Radical Generator
Drug family (ATC) Psoralens for topical use, Psoralens for systemic use
How it works Photoabsorption
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METHOXSALEN 10 MG SOFTGEL Ingredient Methoxsalen
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.

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 mLPer 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 · Q2 2026 $58.20 —
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64380-0752-16 You're viewing this Main listing 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS 2016-12-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methoxsalen 10 mgthis 64380-0752-16 Strides 50 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2016
On the market since
Dec 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color green
ShapeOval
ImprintM10
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

17 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerStrides Pharma Science Limited
Application holderONESOURCE SOFTGELS PTE LTD
FDA applicationANDA202687 (ANDA)
Labeler code64380
First marketedDec 2016
Product typeHuman Prescription Drug
Portfolio195 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 182 words ▾

Methoxsalen with ultraviolet (UV) radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of Psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. For the treatment of patients with psoriasis, photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis is certain.

Because of the possibilities of ocular damage, aging of the skin, and skin cancer (including melanoma), the patient should be fully informed by the physician of the risks inherent in this therapy.

CAUTION: Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patient should be treated in accordance with the dosimetry specifically recommended for this product.

The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined.

🎯 Indications and Usage 59 words ▾

III. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.

⏱️ Dosage and Administration ~3 min read ▾

IX. DRUG DOSAGE & ADMINISTRATION CAUTION: Methoxsalen Capsules, USP represents a new dose form of methoxsalen. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms.

Each patient should be evaluated by determining the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form. Human bioavailability studies have indicated the following drug dosage and administration directions are to be used as a guideline only. PSORIASIS THERAPY 1.

DRUG DOSAGE -INITIAL THERAPY: Methoxsalen capsules should be taken 1-1/2 to 2 hours before UVA exposure with some low-fat food or milk according to the following table: Patient's Weight Dose (kg) (lbs) (mg) <30 <66 10 30-50 66-110 20 51-65 112-143 30 66-80 146-176 40 81-90 179-198 50 91-115 201-254 60 >115 >254 70 Geriatric patients should generally be started at the low end of the dose recommended according to body weight and closely monitored during PUVA therapy. Although clinical experience has not identified differences in response between elderly and younger patients, the use of methoxsalen in older individuals may be affected by the presence of pre-existing medical conditions.

2. INITIAL EXPOSURE: The initial UVA exposure energy level and corresponding time of exposure is determined by the patient's skin characteristics for sun burning and tanning as follows: *Patients with natural pigmentation of these types should be classified into a lower skin type category if the sunburning history so indicates. Skin Type History Recommended J/cm 2 I Always burn, never tan (patients with erythrodermic psoriasis are to be classed as Type I for determination of UVA dosage.)

0.5 J/cm 2 II Always burn, but sometimes tan

1.0 J/cm 2 III Sometimes burn, but always tan

1.5 J/cm 2 IV Never burn, always tan

2.0 J/cm 2 Skin Type Physician Examination J/cm 2 V* Moderately pigmented

2.5 J/cm 2 VI* Blacks

3.0J/cm 2 If the MPD is done, start at 1/2 MPD. Additional drug dosage directions are as follows: Weight Change: In the event that the weight of a patient changes during treatment such that he/she falls into an adjacent weight range/dose category, no change in the dose of methoxsalen is usually required. If, in the physician's opinion, however, a weight change is sufficiently great to modify the drug dose, then an adjustment in the time of exposure to UVA should be made.

Dose/Week: The number of doses per week of methoxsalen capsules will be determined by the patient's schedule of UVA exposures. In no case should treatments be given more often than once every other day because the full extent of phototoxic reactions may not be evident until 48 hours after each exposure. Dosage Increase: Dosage may be increased by 10 mg. after the 15th treatment under the conditions outlined in section XI.B.4.b.

X. UVA RADIATION SOURCE SPECIFICATIONS AND INFORMATION A. IRRADIANCE UNIFORMITY The following specifications should be met with the window of the detector held in a vertical plane: Vertical Variation: For readings taken at any point along the vertical center axis of the chamber (to within 15 cm from the top and bottom), the lowest reading should not be less than 70 % of the highest reading.

Horizontal Variation: Throughout any specific horizontal plane, the lowest reading must be at least 80 % of the highest reading, excluding the peripheral 3 cm of the patient treatment space. B. PATIENT SAFETY FEATURES: The following safety features should be present: (1) Protection from electrical hazard: All units should be grounded and conform to applicable electrical codes.

The patient or operator should not be able to touch any live electrical parts. There should be ground fault protection. (2) Protective shielding of lamps: The patient should not be able to come in contact with the bare lamps.

In the event of lamp breakage, the patient should not be… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 84 words ▾

IV. CONTRAINDICATIONS A. Patients exhibiting idiosyncratic reactions to psoralen compounds.

B. Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.

C. Patients with melanoma or with a history of melanoma. D.

Patients with invasive squamous cell carcinomas. E. Patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.

⚠️ Warnings ~3 min read ▾

V. WARNINGS - GENERAL A. SKIN BURNING: Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded.

B. CARCINOGENICITY: ANIMAL STUDIES: Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice (Hakim et al., 1960 10 ). However, methoxsalen given by the oral route to Swiss albino mice suggests this agent exerts a protective effect against ultraviolet carcinogenesis; mice given 8-methoxypsoralen in their diet showed 38% ear tumors 180 days after the start of ultraviolet therapy compared to 62% for controls (O'Neal et al., 1957 11 ).

HUMAN STUDIES: A 5.7 year prospective study of 1380 psoriasis patients treated with oral methoxsalen and ultraviolet A photochemotherapy (PUVA) demonstrated that the risk of cutaneous squamous-cell carcinoma developing at least 22 months following the first PUVA exposure was approximately 12.8 times higher in the high dose patients than in the low dose patients (Stern et al., 1979 12 , Stern et al., 1980 13 , and Stern et al., 1984 14 ). The substantial dose-dependent increase was observed in patients with neither a prior history of skin cancer nor significant exposure to cutaneous carcinogens.

Reduction in PUVA dosage significantly reduces the risk. No substantial dose-related increase was noted for basal cell carcinoma according to Stern et al., 1984 14 . Increases appear greatest in patients who have pre-PUVA exposure to 1) prolonged tar and UVB treatment, 2) ionizing radiation, or 3) arsenic.

Roenigk et al., 1980 15 , studied 690 patients for up to 4 years and found no increase in the risk of non-melanoma skin cancer, although patients in this cohort had significantly less exposure to PUVA than in the Stern et al. study. Recent analysis of new data in the Stern et al cohort (Stern et al., 1997 16 ) has shown that these patients have an elevated relative risk of contracting melanoma. The relative risk for melanoma in these patients was 2.3 (95% confidence interval 1.1 to 4.1).

The risk is particularly higher in those patients who have received more than 250 PUVA treatments and in those whose treatment has spanned greater than 15 years earlier. Some patients developing melanoma did so even after having ceased PUVA therapy over 5 years earlier. These observations indicate the need for monitoring of PUVA patients for skin tumors throughout their lives.

In a study in Indian patients treated for 4 years for vitiligo, 12% developed keratoses, but not cancer, in the depigmented, vitiliginous areas (Mosher, 1980 17 ). Clinically, the keratoses were keratotic papules, actinic keratosis-like macules, nonscaling dome-shaped papules, and lichenoid porokeratotic-like papules. C.

CATARACTOGENICITY: ANIMAL STUDIES: Exposure to large doses of UVA causes cataracts in animals, and this effect is enhanced by the administration of methoxsalen (Cloud et al., 1960 18 ; Cloud et al., 1961 19 Freeman et al., 1969 20 ). HUMAN STUDIES: It has been found that the concentration of methoxsalen in the lens is proportional to the serum level. If the lens is exposed to UVA during the time methoxsalen is present in the lens, photochemical action may lead to irreversible binding of methoxsalen to proteins and the DNA components of the lens (Lerman et al., 1980 21 ).

However, if the lens is shielded from UVA, the methoxsalen will diffuse out of the lens in a 24-hour period (Lerman et al., 1980 21 ). Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for the 24-hour period following ingestion of methoxsalen whether exposed to direct or indirect sunlight in the open or through a window glass. Among patients using proper eye protection, there is no evidence for a significantly increased risk of cataracts in association with PUVA therapy (Stern et al., 1979 12 ).

Thirty-five of 1380 patients have developed cataracts in the 5 years since their fi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

VII. ADVERSE REACTIONS: A. METHOXSALEN: The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients.

This effect may be minimized or avoided by instructing the patient to take methoxsalen in milk or food, or to divide the dose into two portions, taken approximately one-half hour apart. Other effects include nervousness, insomnia, and depression. B.

COMBINED METHOXSALEN/UVA THERAPY: PRURITUS: This adverse reaction occurs with approximately 10% of all patients. In most cases, pruritus can be alleviated with frequent application of bland emollients or other topical agents; severe pruritus may require systemic treatment. If pruritus is unresponsive to these measures, shield pruritic areas from further UVA exposure until the condition resolves.

If intractable pruritus is generalized, UVA treatment should be discontinued until the pruritus disappears. ERYTHEMA: Mild, transient erythema at 24-48 hours after PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred. Any area showing moderate erythema (greater than Grade 2 - See Table 1 for grades of erythema) should be shielded during subsequent UVA exposures until the erythema has resolved.

Erythema greater than Grade 2 which appears within 24 hours after UVA treatment may signal a potentially severe burn. Erythema may become progressively worse over the next 24 hours, since the peak erythemal reaction characteristically occurs 48 hours or later after methoxsalen ingestion. The patient should be protected from further UVA exposures and sunlight, and should be monitored closely.

IMPORTANT DIFFERENCES BETWEEN PUVA ERYTHEMA AND SUNBURN: PUVA-induced inflammation differs from sunburn or UVB phototherapy in several ways. The % transmission of UVB varies between 0% to 34% through skin whereas UVA varies between 1% to 80% transmission; thus, UVA is transmitted to a larger % through the skin. (Diffey, 1982 22 ).

The DNA lesions induced by PUVA are very different from UV-induced thymine dimers and may lead to a DNA crosslink. This DNA lesion may be more problematic to the cell because crosslinks are more lethal and psoralen-DNA photoproducts may be "new" or unfamiliar substrates for DNA repair enzymes. DNA synthesis is also suppressed longer after PUVA.

The time course of delayed erythema is different with PUVA and may not involve the usual mediators seen in sunburn. PUVA-induced redness may be just beginning at 24 hours, when UVB erythema has already passed its peak. The erythema dose-response curve is also steeper for PUVA.

Compared to equally erythemogenic doses of UVB, the histologic alterations induced by PUVA show more dermal vessel damage and longer duration of epidermal and dermal abnormalities. OTHER ADVERSE REACTIONS: Those reported include edema, dizziness, headache, malaise, depression, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, gastrointestinal disturbances, cutaneous tenderness, leg cramps, hypotension, and extension of psoriasis. To report SUSPECTED ADVERSE REACTION, contact Strides Pharma, Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 7 words ▾

D. DRUG INTERACTIONS: See WARNINGS – GENERAL.

🤰 Pregnancy 47 words ▾

F. PREGNANCY: Animal reproduction studies have not been conducted with methoxsalen. It is also not known whether methoxsalen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methoxsalen should be given to a woman with reproductive capacity only if clearly needed.

🧒 Pediatric Use 48 words ▾

H. PEDIATRIC USE: Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the WARNINGS - GENERAL section as well as the probability of actinic degeneration which is also described in the WARNINGS - GENERAL Section.

🧓 Geriatric Use 91 words ▾

I. GERIATRIC USE: Clinical studies with Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects responded differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 47 words ▾

VIII. OVERDOSAGE In the event of methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is most beneficial within the first 2 to 3 hours after ingestion of methoxsalen, since maximum blood levels are reached by this time.

🧬 Clinical Pharmacology ~3 min read ▾

II. CLINICAL PHARMACOLOGY The combination treatment regimen of psoralen (P) and ultraviolet radiation of 320-400 nm wavelength commonly referred to as UVA is known by the acronym, PUVA. Skin reactivity to UVA (320–400 nm) radiation is markedly enhanced by the ingestion of methoxsalen.

In a well controlled bioavailability study, Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] reached peak drug levels in the blood of test subjects between 0.5 and 4 hours (Mean = 1.8 hours) as compared to between 1.5 and 6 hours (Mean = 3.0 hours) for regular hard gelatin capsule when administered with 8 ounces of milk. Peak drug levels were 2 to 3-fold greater when the overall extent of drug absorption was approximately 2-fold greater for Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] as compared to regular hard gelatin capsules.

Detectable methoxsalen levels were observed up to 12 hours post dose. The drug half-life is approximately 2 hours. Photosensitivity studies demonstrate a shorter time of peak photosensitivity of 1.5 to 2.1 hours vs.

3.9to 4.25 hours for regular hard gelatin capsules. In addition, the mean minimal erythema dose (MED), J/cm 2 , for the Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] is substantially less than that required for regular hard gelatin capsule (Levins et al., 1984 and private communication 1 ). Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells (Artuc et al., 1979 2 ).

At a dose which is 6 times larger than that used in humans, it induces mixed function oxidases in the liver of mice (Mandula et al., 1978 3 ). In both mice and man, methoxsalen is rapidly metabolized. Approximately 95% of the drug is excreted as a series of metabolites in the urine within 24 hours (Pathak et al., 1977 4 ).

The exact mechanism of action of methoxsalen with the epidermal melanocytes and keratinocytes is not known. The best known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional (crosslinking of psoralen to both strands of DNA) adducts (Dall' Acqua et al., 1971 5 ; Cole, 1970 6 ; Musajo et al., 1974 7 ; Dall' Acqua et al., 1979 8 ).

Reactions with proteins have also been described (Yoshikawa, et al., 1979 9 ). Methoxsalen acts as a photosensitizer. Administration of the drug and subsequent exposure to UVA can lead to cell injury.

Orally administered methoxsalen reaches the skin via the blood and UVA penetrates well into the skin. If sufficient cell injury occurs in the skin, an inflammatory reaction occurs. The most obvious manifestation of this reaction is delayed erythema, which may not begin for several hours and peaks at 48-72 hours.

The inflammation is followed, over several days to weeks, by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. The mechanisms of therapy are not known. In the treatment of psoriasis, the mechanism is most often assumed to be DNA photodamage and resulting decrease in cell proliferation but other vascular, leukocyte, or cell regulatory mechanisms may also be playing some role.

Psoriasis is a hyperproliferative disorder and other agents known to be therapeutic for psoriasis are known to inhibit DNA synthesis.

📦 How Supplied / Storage and Handling 86 words ▾

XII. HOW SUPPLIED Methoxsalen Capsules, USP 10 mg is green color, oval shaped soft gelatin capsule imprinted with 'M10' containing no drug crystals and clear colorless to pale yellow liquid, each containing 10 mg of methoxsalen (8-methoxypsoralen). It is packed in amber colored glass bottles as 50's count (NDC 64380-752-16).

Store at 20° to 25 °C (68° to 77 °F); excursions permitted between 15 °C - 30 °C (59 °F - 86 °F). [See USP Controlled Room Temperature] Distributed by: Strides Pharma, Inc. Bridgewater, NJ 08807

📋 Description 167 words ▾

I. DESCRIPTION Methoxsalen Soft Gelatin Capsules USP contains 10mg methoxsalen. Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of Ammi majus and roots of Heracleum Candicans or through synthesis.

Methoxsalen is practically insoluble in water, freely soluble in chloroform, soluble in boiling alcohol, in acetone, in acetic acid, in propylene glycol, and in benzene, sparingly soluble in boiling water and in ether. The chemical name of methoxsalen is 9-methoxy-7H-furo [3,2-g] [1] benzopyran-7-one; its empirical formula is C 12 H 8 O 4 and the molecular weight is 216.19. The structural formula is: Methoxsalen Capsules are available as soft gelatin capsules containing the following inactive ingredients: Citric acid anhydrous, D & C yellow 10, FD & C blue 1, Gelatin, Glycine, Glycerin, Isopropyl alcohol, Medium chain triglyceride, Polyethylene glycol 400, Polysorbate 80, Purified water, Titanium dioxide and Opacode black.

The opacode black contains Propylene glycol, Shellac glaze (Modified) IN SD-45, N-Butyl alcohol, Black iron oxide, Isopropyl alcohol and Ammonium hydroxide. Methoxsalen

💬 Information for Patients 9 words ▾

B. INFORMATION FOR PATIENTS: See accompanying Patient Package Insert.

💬 Medication Guide ~3 min read ▾

PATIENT INFORMATION ON THE USE OF METHOXSALEN CAPSULES, USP 10 MG [SOFT GELATIN CAPSULES] IN THE TREATMENT OF PSORIASIS This brochure is intended to provide you with information about the treatment of psoriasis. The entire brochure should be read so that you are aware of the requirements on your part to ensure the effectiveness and safety of the therapy. Any additional questions that you may have can be answered by your doctor or pharmacist.

In addition, the pharmacist will have a copy of a very technical brochure entitled the "Physician's Package Insert" that you may wish to read. A. What Is Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]?

Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] is a drug which has been shown to be effective in the treatment of psoriasis when combined with exposure to a very specific kind of light. The use of the drug must be combined with exposure to the special light to produce effective therapy. Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] represents a new dose form of methoxsalen.

This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. B. What Is The Special Light?

Light is classified into many different parts. One part is known as ultraviolet light, which is a normal component of sunlight. Artificial or man-made light sources are now available that produce the special part of light (ultraviolet "A") necessary for the most effective therapy.

C. What Is "PUVA"? "PUVA" is the name of the treatment for psoriasis and stands for the use of Psoralen drug (Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]) in combination with UltraViolet A light. D.

What Is Psoriasis? Psoriasis is a skin condition associated with red and scaly patches. The cause of psoriasis is not known.

PUVA (Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] with ultraviolet A light) is used for the treatment of severe psoriasis that has not been helped by other methods of therapy. E. What Should The Patient Do Before PUVA Therapy?

Certain other medicines can make you more sensitive to the combination drug and light treatment. In addition, certain other medical conditions can be aggravated by this treatment. Before starting treatment, be sure to tell your doctor if you have experienced any of the following: had a severe reaction to Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] in the past had recent x-ray treatment or planning any have or ever have had skin cancer have or ever have had any eye problems such as cataracts or loss of the lens of the eyes have or ever have had liver problems have or ever have had heart or blood pressure problems have any medical condition that requires you to stay out of the sun such as lupus erythematosus are taking any drugs (either prescription or nonprescription).

Some drugs can increase your sensitivity to ultraviolet light either from the sun or man-made sources. Examples of such drugs include major tranquilizers, sulfa drugs for the treatment of infection or diabetes, tetracycline, antibiotics, griseofulvin products, thiazide-containing diuretics (blood pressure or water elimination drugs), and certain antibacterial or deodorant soaps F. How Should The Patient Take Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]?

The number of capsules recommended by your doctor should be taken with some food or low fat milk two hours before ultraviolet light treatment. Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules] is a potent drug . Never take more than is prescribed for you since it may result in burning and/or blistering of your skin after exposure to ultraviolet light.

G. What Precautions Should Be Taken During And After PUVA Therapy? Eye Protection — Make sure that you wear special wrap-around sunglasses that totally block or absorb ultraviolet light.

Put them on immediately after taking Methoxsalen Capsules, USP 10 mg [Soft Gelatin] and… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

VI. PRECAUTIONS A. GENERAL - APPLICABLE TO PSORIASIS TREATMENT: BEFORE METHOXSALEN INGESTION Patients must not sunbathe during the 24 hours prior to methoxsalen ingestion and UV exposure.

The presence of a sunburn may prevent an accurate evaluation of the patient's response to photochemotherapy. AFTER METHOXSALEN INGESTION UVA-absorbing wrap-around sunglasses should be worn during daylight for 24 hours after methoxsalen ingestion. The protective eyewear must be designed to prevent entry of stray radiation to the eyes, including that which may enter from the sides of the eyewear.

The protective eyewear is used to prevent the irreversible binding of methoxsalen to the proteins and DNA components of the lens. Cataracts form when enough of the binding occurs. Visual discrimination should be permitted by the eyewear of patient well-being and comfort.

Patients must avoid sun exposure, even through window glass or cloud cover, for at least 8 hours after methoxsalen ingestion. If sun exposure cannot be avoided, the patient should wear protective devices such as a hat and gloves, and/or apply sunscreens which contain ingredients that filter out UVA radiation (e.g., sunscreens containing benzophenone and/or PABA esters which exhibit a sun protective factor equal to or greater than 15). These chemical sunscreens should be applied to all areas that might be exposed to the sun (including lips).

Sunscreens should not be applied to areas affected by psoriasis until after the patient has been treated in the UVA chamber. DURING PUVA THERAPY Total UVA-absorbing/blocking goggles mechanically designed to give maximal ocular protection must be worn. Failure to do so may increase the risk of cataract formation.

A reliable radiometer can be used to verify elimination of UVA transmission through the goggles. Abdominal skin, breasts, genitalia, and other sensitive areas should be protected for approximately 1/3 of the initial exposure time until tanning occurs. Unless affected by disease, male genitalia should be shielded.

AFTER COMBINED METHOXSALEN/UVA THERAPY UVA-absorbing wrap-around sunglasses should be worn during daylight for 24 hours after combined methoxsalen/UVA therapy. Patients should not sunbathe for 48 hours after therapy. Erythema and/or burning due to photochemotherapy and sunburn due to sun exposure are additive.

🍼 Nursing Mothers 31 words ▾

G. NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, either methoxsalen ingestion or nursing should be discontinued.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 6 words ▾

E. CARCINOGENESIS: See WARNINGS – GENERAL.

📚 References ~3 min read ▾

BIBLIOGRAPHY Levins, P.C., Gange, R.W., Momtaz-T,K., Parrish, J.A., and Fitzpatrick, T.B.: A New Liquid Formulation of 8-Methoxypsoralen: Bioactivity and Effect of Diet: JID, 82 , No. 2, pp. 185-187 (1984) and private communication.

Artuc, M., Stuettgen, G., Schalla, W., Schaefer, H., and Gazith, J.: Reversible binding of 5- and 8-methoxypsoralen to human serum proteins (albumin) and to epidermis in vitro: Brit. J. Dermat.

101 , pp. 669-677 (1979). Mandula, B.B., Pathak, M.A., Nakayama, T., and Davidson, S.J.: Induction of mixed-function oxidases in mouse liver by psoralens., Ibid, 99 , pp.

687-692 (1978). Pathak, M. A., Fitzpatrick, T.

B., Parrish, J. A.: PSORIASIS, Proceedings of the Second International Symposium. Edited by E.M.

Farber, A.J. Cox, Yorke Medical Books, pp. 262-265 (1977).

Dall'Acqua, F., Marciani, S., Ciavatta, L., Rodighiero, G.: Formation of interstrand cross-linkings in the photoreactions between furocoumarins and DNA; Z Naturforsch (B), 26, pp. 561-569 (1971). Cole, R.

S.: Light-induced cross-linkings of DNA in the presence of a furocoumarin (psoralen), Biochem. Biophys. Acta, 217 , pp.

30-39 (1970). Musajo, L., Rodighiero, G., Caporale, G., Dall'Acqua, F., Marciani, S., Bordin, F., Baccichetti, F., Bevilacqua, R.: Photoreactions between Skin-Photosensitizing Furocoumarins and Nucleic Acids, Sunlight and Man ; Normal and Abnormal Photobiologic Responses. Edited by M.

A. Pathak, L. C.

Harber, M. Seiji et al. University of Tokyo Press, pp.

369-387 (1974). Dall'Acqua, F., Vedaldi, D., Bordin, F., and Rodighiero, G.: New studies in the interaction between 8-methoxypsoralen and DNA in vitro ; JID, 73 , pp. 191-197 (1979).

Yoshikawa, K., Mori, N., Sakakibara, S., Mizuno, N., Song, P.: Photo Conjugation of 8-methoxypsoralen with Proteins; Photochem. & Photobiol. 29 , pp. 1127-1133 (1979).

Hakim, R.D., Griffin, A.C.: Knox, J.M.: Erythema and tumor formation in methoxsalen treated mice exposed to fluorescent light; Arch. Dermatol. 82 , pp.

572-577 (1960). O'Neal, M.A., Griffin, A.C.: The Effect of Oxypsoralen upon Ultraviolet Carcinogenesis in Albino Mice, Cancer Res., 17, pp. 911-916 (1957).

Stern, R.S., Unpublished personal communication. Stern, R.S., Parrish, J.A., Zierler, S.: Skin Carcinoma in Patients with Psoriasis Treated with Topical Tar and Artificial Ultraviolet Radiation. Lancet, 1 , pp.

732-735 (1980). Stern, R.S., Laird, N., Melski, J., Parrish, J.A., Fitzpatrick, T.B., Bleich, H.L.: Cutaneous Squamous-Cell Carcinoma in Patients Treated with PUVA: NEJM, 310, No. 18, pp.

1156-1161 (1984). Roenigk, Jr., H.H., and 12 Cooperating Investigators: Skin Cancer in the PUVA-48 Cooperative Study of Psoriasis. Program for Forty-First Annual Meeting for The Society of Investigative Dermatology, Inc., Sheraton Washington Hotel, Washington, D.C., May 12, 13, and 14, 1980.

Abstract JID, 74 No. 4, pp. 250 (April 1980).

Stern et al., Malignant melanoma in patients treated for psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). The PUVA Follow-Up Study. New England Journal of Medicine, 336:1041-1045, (April 10, 1997).

Mosher, D.B., Pathak, M.A., Harris, T.J., Fitzpatrick, T.B.: Development of Cutaneous Lesions in Vitiligo During Long-Term PUVA Therapy. Program for Forty-First Annual Meeting for The Society for Investigative Dermatology, Inc., Sheraton Washington Hotel, Washington, D.C., May 12, 13, and 14, 1980. Abstracts JID, 74 , No.

4, p. 259 (April, 1980). Cloud, T.M., Hakim, R., Griffin, A.C.: Photosensitization of the eye with methoxsalen.

I. Acute effects; Arch. Ophthalmol.

64 , pp. 346-352 (1960). Cloud, T.

M., Hakim, R., Griffin, A. C.: Photosensitization of the eye with methoxsalen. II.

Chronic effects, Ibid, 66 , pp. 689-694 (1961). Freeman, R.

G., Troll, D.: Photosensitization of the eye by 8-methoxypsoralen, JID, 53 , pp. 449-453 (1969). Lerman, S., Megaw, J., Willis, I.: Potential ocular complications from PUVA therapy and their prevention; JID 74 , pp.

197-199 (1980). Diffey, >L., M… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 67 words ▾

PRINCIPAL DISPLAY PANEL NDC 64380-752-16 Rx Only (Methoxsalen Capsules, USP) 10 mg CAUTION: This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Each patient should be evaluated by determining the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photoche-motheraphy with this dosage form. 50 Capsules 10 mg-50s-Carton-Label 10 mg-50s-Container-Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methoxsalen — 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 Methoxsalen. 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
$98.4K
Claims incl. refills
67
Beneficiaries
43
Spend / beneficiary
$2,289.27
Spend / claim
$1,469.23
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 METHOXSALEN — the ingredient across all brands.

Top reported reactions

Vomiting13
Dysphagia12
Fatigue10
Drug Intolerance9
Pruritus9
Cardiac Failure8
Condition Aggravated8

Age at onset

Neonate1
Infant2
Adult10
Elderly9

Reporter sex

123 reports
Male · 47%
Female · 53%

Serious outcomes

Hospitalization30
Life-threatening7
Death6
Disabling4
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 16 6
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.

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) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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.
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.
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 Strides Pharma Science Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strides Pharma Science Limited 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.
← 64380-0751-01 · Strides 64380-0753-01 · Strides →
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.