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Edaravone 30 mg/100mL Injection — NDC 00781-3527-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Edaravone 30 mg/100mL Injection — NDC 0781-3527-20 (Billing 00781-3527-20)

by Sandoz Inc · 2 BAG in 1 CARTON / 100 mL in 1 BAG

This is a package of Edaravone 30 mg/100mL Injection from Sandoz Inc, marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 00781-3527-20
🏷️ FDA NDC (as labeled) 0781-3527-20 billing pads the labeler 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

NDC database record

One package, one record: these facts belong to NDC 0781-3527-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0781 labeler · 3527 product · 20 package
Package marketed since
Jan 21, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0781352720 6
Medicaid fills, this package
20 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0781-3527-20
Product NDC 0781-3527
11-digit billing NDC 00781352720
NCPDP billing unit ML — per mL (volume)
RxCUI 1924316
UNII S798V6YJRP
Application # ANDA216902
SPL Set ID ae940bc6-1e6a-4b76-825c-bd2e1925e39a
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-21
Route INTRAVENOUS
Dosage form INJECTION
Substance EDARAVONE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 74509030002010
GCN Seq No 077389
GCN 43378
HICL code 044252
Ingredient (HICL) Edaravone
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6I
Therapeutic class — specific (HIC3) Amyotrophic Lateral Sclerosis Agents
AHFS code 28:44.00.00
AHFS class Amyotrophic Lateral Sclerosis(Als) Agent
FDB label name EDARAVONE 30 MG/100 ML BAG
FDB brand name Edaravone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077389
  • GCN: 43378
  • GPI-14 (Medi-Span): 74509030002010
  • HICL (First Databank): 044252
  • AHFS class code: 28:44.00.00
  • RxCUI (RxNorm): 1924316
Why two NDCs? The FDA registers this code as 0781-3527-20 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00781-3527-20. 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 Other nervous system drugs class.

Drug family (ATC) Other nervous system drugs
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 EDARAVONE 30 MG/100 ML BAG Ingredient Edaravone
📖 What it is MedlinePlus · NLM

Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken). Edaravone injection is in a class of medications called antioxidants. It may work to slow the nerve damage associated with the worsening of ALS symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Radicava is approved to treat ALS — amyotrophic lateral sclerosis, sometimes called Lou Gehrig's disease. It's a progressive condition that damages the nerve cells that control you...
  • Radicava is given as an IV infusion, which means it goes directly into a vein through a drip over about 60 minutes. A healthcare professional administers each dose. It follows a cy...
  • How is this medication given — do I take it at home?
  • The most common ones seen in studies were bruising, trouble walking, and headache. Skin reactions like rash or eczema were also reported. The most serious concern is a severe aller...
📖 Read our full Edaravone Injection guide →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $588.75 $1,177.50 / 2 bags
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1301 $6.463 / J1301 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)0781-3527-20
11-digit billing NDC00781-3527-20
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1301
DescriptorInjection, edaravone, 1 mg
Billing units / pkg60 units
How the units are derivedThis package is 100; the HCPCS unit is 1 MG, so one package = 60 billing units.
Medicare Part B spend (2026 (Q1))$108,310 · 53 claims · $2,043.59 per claim (all NDCs under J1301)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00781-3527-20 You're viewing this Main listing 2 BAG in 1 CARTON / 100 mL in 1 BAG 2025-01-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Edaravone 30 mg/100mLthis 00781-3527-20 Sandoz 100 ml — AP FDA listed —
Edaravone 30 mg/100mL 66794-0259-64 Piramal 2 pouches — AP FDA listed —
edaravone 30 mg/100mL 68083-0500-02 Gland 2 pouches — AP 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

  • 10 mg / 100 mL UNII ZT934N0X4W
    A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • 20 mg / 100 mL UNII TZX5469Z6I
    Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

6 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

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA216902 (ANDA)
Labeler code00781
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio391 products on file

More NDCs from Sandoz Inc labeler code 00781

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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

1 INDICATIONS AND USAGE Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows: • Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period ( 2.1 ) • Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods ( 2.1 )

2.1Dosage Information The recommended dosage of edaravone injection is an intravenous infusion of 60 mg administered over a 60-minute period according to the following schedule: • An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period • Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods

2.2Preparation and Administration Information for Edaravone Injection Edaravone injection is for intravenous infusion only. Preparation Do not use if the yellow oxygen indicator has turned green or blue before opening the package. Once the overwrap package is opened, use within 24 hours.

Discard unused portion [see How Supplied/Storage and Handling ( 16.1 , 16.2 )] . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administration Administer each 60 mg dose of edaravone injection as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).

Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see Warnings and Precautions ( 5.1 , 5.2 )] . Other medications should not be injected into the infusion bag or mixed with edaravone injection.

2.4Switching from Edaravone Injection to Radicava ORS Patients treated with 60 mg of edaravone injection intravenous infusion may be switched to 105 mg (5 mL) Radicava ORS using the same dosing frequency.

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS Edaravone injection is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless, and free from visible particle aqueous solution. • Injection: 30 mg/100 mL in a single-dose polypropylene bag ( 3 )

⛔ Contraindications 61 words ▾

4 CONTRAINDICATIONS Edaravone injection is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred [see Warnings and Precautions ( 5.1 , 5.2 )] . Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in edaravone injection ( 4 )

⚠️ Warnings and Cautions 157 words ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Advise patients to seek immediate medical care ( 5.1 ) • Sulfite Allergic Reactions: Edaravone injection contains sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible people ( 5.2 )

5.1Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with edaravone injection. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue edaravone injection, treat per standard of care, and monitor until the condition resolves [see Contraindications ( 4 )].

5.2Sulfite Allergic Reactions Edaravone injection contains sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Sulfite Allergic Reactions [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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 randomized, placebo-controlled trials, 184 patients with ALS were administered edaravone injection 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29-75) and were 59% male.

Most (93%) of these patients were living independently at the time of screening. Most Common Adverse Reactions Observed During Clinical Studies Table 2 lists the adverse reactions that occurred in ≥ 2% of patients in the edaravone injection-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials. The most common adverse reactions that occurred in ≥10% of edaravone injection-treated patients were contusion, gait disturbance, and headache.

Table 2: Adverse Reactions from Pooled Placebo-Controlled Trials * that Occurred in ≥ 2% of Edaravone Injection-Treated Patients and ≥ 2% More Frequently than in Placebo Patients Adverse Reaction Edaravone Injection (N=184) % Placebo (N=184) % Contusion 15 9 Gait disturbance 13 9 Headache 10 6 Dermatitis 8 5 Eczema 7 4 Respiratory failure, respiratory disorder, hypoxia 6 4 Glycosuria 4 2 Tinea infection 4 2 * Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen [see Clinical Studies ( 14 )] .

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of edaravone injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis. [see Warnings and Precautions ( 5.1 , 5.2 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of edaravone injection in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development, and altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity ( see Animal Data ).

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. The background risk for major birth defects and miscarriage in patients with ALS is unknown. Data Animal Data In rats, intravenous administration of edaravone (0, 3, 30, or 300 mg/kg/day) throughout the period of organogenesis resulted in reduced fetal weight at all doses.

In dams allowed to deliver naturally, offspring weight was reduced at the highest dose tested. Maternal toxicity was also observed at the highest dose tested. There were no adverse effects on reproductive function in the offspring.

A no-effect dose for embryofetal developmental toxicity was not identified; the low dose is less than the recommended human dose of 60 mg for edaravone injection, on a body surface area (mg/m 2 ) basis. In rabbits, intravenous administration of edaravone (0, 3, 20, or 100 mg/kg/day) throughout the period of organogenesis resulted in embryofetal death at the highest dose tested, which was associated with maternal toxicity. The higher no-effect dose for embryofetal developmental toxicity is approximately 6 times the recommended human dose (RHD) for edaravone injection on a body surface area (mg/m 2 ) basis.

The effects on offspring of edaravone (0, 3, 20, or 200 mg/kg/day), administered by intravenous injection to rats from GD 17 throughout lactation, were assessed in two studies. In the first study, offspring mortality was observed at the high dose and increased activity was observed at the mid and high doses. In the second study, there was an increase in stillbirths, offspring mortality, and delayed physical development (vaginal opening) at the highest dose tested.

Reproduction function in offspring was not affected in either study. Maternal toxicity was evident in both studies at all but the lowest dose tested. The no-effect dose for developmental toxicity (3 mg/kg/day) is less than the RHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Edaravone and its metabolites are excreted in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for edaravone injection and any potential adverse effects on the breastfed infant from edaravone injection or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established.

8.5Geriatric Use Of the 184 patients with ALS who received edaravone injection in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of edaravone injection in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development, and altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity ( see Animal Data ).

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. The background risk for major birth defects and miscarriage in patients with ALS is unknown. Data Animal Data In rats, intravenous administration of edaravone (0, 3, 30, or 300 mg/kg/day) throughout the period of organogenesis resulted in reduced fetal weight at all doses.

In dams allowed to deliver naturally, offspring weight was reduced at the highest dose tested. Maternal toxicity was also observed at the highest dose tested. There were no adverse effects on reproductive function in the offspring.

A no-effect dose for embryofetal developmental toxicity was not identified; the low dose is less than the recommended human dose of 60 mg for edaravone injection, on a body surface area (mg/m 2 ) basis. In rabbits, intravenous administration of edaravone (0, 3, 20, or 100 mg/kg/day) throughout the period of organogenesis resulted in embryofetal death at the highest dose tested, which was associated with maternal toxicity. The higher no-effect dose for embryofetal developmental toxicity is approximately 6 times the recommended human dose (RHD) for edaravone injection on a body surface area (mg/m 2 ) basis.

The effects on offspring of edaravone (0, 3, 20, or 200 mg/kg/day), administered by intravenous injection to rats from GD 17 throughout lactation, were assessed in two studies. In the first study, offspring mortality was observed at the high dose and increased activity was observed at the mid and high doses. In the second study, there was an increase in stillbirths, offspring mortality, and delayed physical development (vaginal opening) at the highest dose tested.

Reproduction function in offspring was not affected in either study. Maternal toxicity was evident in both studies at all but the lowest dose tested. The no-effect dose for developmental toxicity (3 mg/kg/day) is less than the RHD on a mg/m 2 basis.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Of the 184 patients with ALS who received edaravone injection in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which edaravone injection exerts its therapeutic effect in patients with ALS is unknown.

12.2Pharmacodynamics Cardiac Electrophysiology At exposures at least 5 times higher than that of the recommended dose of edaravone injection, edaravone does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Edaravone injection is administered by IV infusion. The maximum plasma concentration (C max ) of edaravone was reached by the end of infusion. There was a trend of more than dose-proportional increase in area under the concentration-time curve (AUC) and C max of edaravone.

With multiple-dose administration, edaravone does not accumulate in plasma. Distribution Edaravone is bound to human serum proteins (92%), mainly to albumin, with no concentration dependence in the range of 0.1 to 50 micromol/L. Edaravone has a mean volume of distribution after intravenous administration of

63.1L. Elimination The mean terminal elimination half-life of edaravone is approximately 4.5 to 9 hours. The half-lives of its metabolites are 3 to 6 hours. Following intravenous administration, the total clearance of edaravone is estimated to be

35.9L/h. Metabolism Edaravone is metabolized to a sulfate conjugate and a glucuronide conjugate, which are not pharmacologically active. The glucuronide conjugation of edaravone involves multiple uridine diphosphate glucuronosyltransferase (UGT) isoforms (UGT1A1, UGT1A6, UGT1A7, UGT1A8, UGT1A9, UGT1A10, UGT2B7, and UGT2B17).

In human plasma, edaravone is mainly detected as the sulfate conjugate, which is presumed to be formed by sulfotransferases. Excretion In Japanese and Caucasian healthy volunteer studies, edaravone was excreted mainly in the urine as its glucuronide conjugate (60-80% of the dose up to 48 hours). Approximately 6-8% of the dose was recovered in the urine as the sulfate conjugate, and <1% of the dose was recovered in the urine as the unchanged drug.

In vitro studies suggest that the sulfate conjugate of edaravone is hydrolyzed back to edaravone, which is then converted to the glucuronide conjugate in the kidney before excretion into the urine. Specific Populations Geriatric Patients No age effect on edaravone pharmacokinetics has been found [see Use in Specific Populations ( 8.5 )] . Patients with Renal Impairment Following single IV infusion of 30 mg edaravone (half the recommended dosage of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.15-and 1.20-fold greater in the subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m 2 ) and were 1.25-and 1.29-fold greater in the subjects with moderate renal impairment (eGFR 30-59 mL/min/1.73m 2 ) when compared to subjects with normal renal function, respectively.

These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with mild to moderate renal impairment. The effects of severe renal impairment on the pharmacokinetics of edaravone have not been studied. Patients with Hepatic Impairment Following single IV infusion of 30 mg edaravone (half of the recommended dose of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.20-and 1.07-fold greater in the subjects with mild hepatic impairment (Child-Pugh score 5 or 6), were 1.24-and 1.14-fold greater in the subjects with moderate hepatic impairment (Child-Pugh score 7 to 9), and were 1.20-and 1.19-fold greater in the subjects with severe hepatic impairment (Child-Pugh score 10 to 14) when compared to subjects with normal hepatic function, respectively.

These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with hepatic impairment. Male and Female Patients No gender effect on edaravone pharmacokinetics has been found. Racial or Ethnic Groups There were no significant raci… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action The mechanism by which edaravone injection exerts its therapeutic effect in patients with ALS is unknown.

📦 How Supplied / Storage and Handling 180 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Edaravone Injection is supplied as a 30 mg/100 mL (0.3 mg/mL) clear, colorless, and free from visible particle sterile solution for intravenous infusion in single-dose polypropylene bags, each over-wrapped on the front with transparent Aten film and on the back with four-layer formable film as secondary packaging containing an oxygen absorber and oxygen indicator, which should be yellow to reflect appropriate oxygen levels [see Dosage and Administration ( 2.2 ) and How Supplied/Storage and Handling ( 16.2 )] .

These are supplied in cartons as listed below. NDC 0781-3527-94 30 mg/100 mL (0.3 mg/mL) Single-Dose bag NDC 0781-3527-20 2 bags per carton

16.2Storage and Handling Store edaravone injection at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use. The yellow oxygen indicator will turn green or blue if the oxygen has exceeded acceptable levels. Once the overwrap package is opened, use within 24 hours.

📋 Description 182 words ▾

11 DESCRIPTION The active ingredient in edaravone injection is edaravone, which is a member of the substituted 2-pyrazolin-5-one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. Molecular formula: C 10 H 10 N 2 O Molecular weight: 174.20 Chemical structure: Edaravone is a white to yellowish powder with a melting point of 129.7°C.

It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether. Edaravone injection is a clear, colorless, and free from visible particle liquid provided as a sterile solution. Edaravone injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further over-wrapped on the front with transparent Aten film and on the back with four-layer formable film as secondary packaging.

The over-wrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4. chem-structure

💬 Information for Patients 175 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patients to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction [see Warnings and Precautions ( 5.1 )]. Sulfite Allergic Reactions Advise patients about potential for sulfite sensitivity.

Inform patients that edaravone injection contains sodium bisulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, and to seek immediate medical care if they experience these signs or symptoms [see Warnings and Precautions ( 5.2 )]. Pregnancy and Breastfeeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during edaravone injection therapy [see Use in Specific Populations ( 8.1 )] .

Advise patients to notify their healthcare provider if they intend to breastfeed or are breastfeeding an infant [see Use in Specific Populations ( 8.2 )] . Manufactured by InfoRLife SA for Sandoz Inc., Princeton, NJ 08540 RADICAVA ORS ® is a registered trademark of Mitsubishi Tanabe Pharma Corporation.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Edaravone injection is administered by IV infusion. The maximum plasma concentration (C max ) of edaravone was reached by the end of infusion. There was a trend of more than dose-proportional increase in area under the concentration-time curve (AUC) and C max of edaravone.

With multiple-dose administration, edaravone does not accumulate in plasma. Distribution Edaravone is bound to human serum proteins (92%), mainly to albumin, with no concentration dependence in the range of 0.1 to 50 micromol/L. Edaravone has a mean volume of distribution after intravenous administration of

63.1L. Elimination The mean terminal elimination half-life of edaravone is approximately 4.5 to 9 hours. The half-lives of its metabolites are 3 to 6 hours. Following intravenous administration, the total clearance of edaravone is estimated to be

35.9L/h. Metabolism Edaravone is metabolized to a sulfate conjugate and a glucuronide conjugate, which are not pharmacologically active. The glucuronide conjugation of edaravone involves multiple uridine diphosphate glucuronosyltransferase (UGT) isoforms (UGT1A1, UGT1A6, UGT1A7, UGT1A8, UGT1A9, UGT1A10, UGT2B7, and UGT2B17).

In human plasma, edaravone is mainly detected as the sulfate conjugate, which is presumed to be formed by sulfotransferases. Excretion In Japanese and Caucasian healthy volunteer studies, edaravone was excreted mainly in the urine as its glucuronide conjugate (60-80% of the dose up to 48 hours). Approximately 6-8% of the dose was recovered in the urine as the sulfate conjugate, and <1% of the dose was recovered in the urine as the unchanged drug.

In vitro studies suggest that the sulfate conjugate of edaravone is hydrolyzed back to edaravone, which is then converted to the glucuronide conjugate in the kidney before excretion into the urine. Specific Populations Geriatric Patients No age effect on edaravone pharmacokinetics has been found [see Use in Specific Populations ( 8.5 )] . Patients with Renal Impairment Following single IV infusion of 30 mg edaravone (half the recommended dosage of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.15-and 1.20-fold greater in the subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m 2 ) and were 1.25-and 1.29-fold greater in the subjects with moderate renal impairment (eGFR 30-59 mL/min/1.73m 2 ) when compared to subjects with normal renal function, respectively.

These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with mild to moderate renal impairment. The effects of severe renal impairment on the pharmacokinetics of edaravone have not been studied. Patients with Hepatic Impairment Following single IV infusion of 30 mg edaravone (half of the recommended dose of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.20-and 1.07-fold greater in the subjects with mild hepatic impairment (Child-Pugh score 5 or 6), were 1.24-and 1.14-fold greater in the subjects with moderate hepatic impairment (Child-Pugh score 7 to 9), and were 1.20-and 1.19-fold greater in the subjects with severe hepatic impairment (Child-Pugh score 10 to 14) when compared to subjects with normal hepatic function, respectively.

These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with hepatic impairment. Male and Female Patients No gender effect on edaravone pharmacokinetics has been found. Racial or Ethnic Groups There were no significant racial differences in Cmax and AUC of edaravone between Japanese and Caucasian subjects.

Drug Interaction Studies The pharmacokinetics of edaravone is not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters. In vitro studies demonstrated that, at the recommended dosage, edaravone and its metabolites are not expected t… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 32 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At exposures at least 5 times higher than that of the recommended dose of edaravone injection, edaravone does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of edaravone injection for the treatment of ALS was established in a 6-month, randomized, placebo-controlled, double-blind study conducted in Japanese patients with ALS who were living independently and met the following criteria at screening: 1. Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]) 2. Normal respiratory function (defined as percent-predicted forced vital capacity values of [%FVC] ≥ 80%) 3.

Definite or Probable ALS based on El Escorial revised criteria 4. Disease duration of 2 years or less The study enrolled 69 patients in the edaravone injection arm and 68 in the placebo arm. Baseline characteristics were similar between these groups, with over 90% of patients in each group being treated with riluzole.

Edaravone injection was administered as an intravenous infusion of 60 mg given over a 60-minute period according to the following schedule: • An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period (Cycle 1) • Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods (Cycles 2-6). The primary efficacy endpoint was a comparison of the change between treatment arms in the ALSFRS-R total scores from baseline to Week 24. The ALSFRS-R scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of patients with ALS (speech, salivation, swallowing, handwriting, cutting food, dressing/hygiene, turning in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency).

Each item is scored from 0-4, with higher scores representing greater functional ability. The decline in ALSFRS-R scores from baseline was significantly less in the edaravone injection-treated patients as compared to placebo (see Table 3 ). The distribution of change in ALSFRS-R scores from baseline to Week 24 by percent of patients is shown in Figure 1 .

Table 3: Analysis of Change from Baseline to Week 24 in ALSFRS-R Scores Treatment Change from Baseline LS Mean ± SE (95% CI) Treatment Difference (Edaravone Injection – placebo [95% CI]) p -value Edaravone Injection −5.01±0.64 2.49 (0.99, 3.98) 0.0013 Placebo −7.50±0.66 Figure 1: Distribution of Change from Baseline to Week 24 in ALSFRS-R Scores figure-1

🧪 Nonclinical Toxicology 130 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of edaravone using the intravenous route have not been conducted. Mutagenesis Edaravone was negative in in vitro (bacterial reverse mutation and Chinese hamster lung chromosomal aberration) and in vivo (mouse micronucleus) assays. Impairment of Fertility Intravenous administration of edaravone (0, 3, 20, or 200 mg/kg) prior to and throughout mating in male and female rats and continuing in females to gestation day 7 had no effect on fertility; however, disruption of the estrus cycle and mating behavior was observed at the highest dose tested.

No effects on reproductive function were observed at the lower doses, which are up to approximately 3 times the RHD for edaravone injection (60 mg) on a body surface area (mg/m 2 ) basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 127 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of edaravone using the intravenous route have not been conducted. Mutagenesis Edaravone was negative in in vitro (bacterial reverse mutation and Chinese hamster lung chromosomal aberration) and in vivo (mouse micronucleus) assays. Impairment of Fertility Intravenous administration of edaravone (0, 3, 20, or 200 mg/kg) prior to and throughout mating in male and female rats and continuing in females to gestation day 7 had no effect on fertility; however, disruption of the estrus cycle and mating behavior was observed at the highest dose tested.

No effects on reproductive function were observed at the lower doses, which are up to approximately 3 times the RHD for edaravone injection (60 mg) on a body surface area (mg/m 2 ) basis.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Edaravone Injection for Intravenous Infusion (e-DAR-a-vone) What is edaravone injection? Edaravone injection is a prescription medicine used to treat people with amyotrophic lateral sclerosis (ALS). It is not known if edaravone injection is safe and effective in children.

Do not receive edaravone injection if you are allergic to edaravone or any of the ingredients in edaravone injection. See the end of this leaflet for a complete list of ingredients in edaravone injection. Before you take edaravone injection, tell your healthcare provider about all of your medical conditions, including if you: • have asthma. • are allergic to other medicines. • are pregnant or plan to become pregnant.

It is not known if edaravone injection will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if edaravone passes into your breastmilk. You and your healthcare provider should decide if you will receive edaravone injection or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive edaravone injection? • You will be prescribed edaravone injection by a healthcare provider and told how often you will receive edaravone injection. • Edaravone injection will be given by intravenous (IV) infusion into your vein. • It takes about 1 hour to receive the full dose of edaravone injection. • Your healthcare provider will monitor you closely during your treatment with edaravone injection.

What are the possible side effects of edaravone injection? Edaravone injection may cause serious side effects including: 1. Hypersensitivity (allergic) reactions.

Hypersensitivity reactions have happened in people receiving edaravone injection and can happen after your infusion is finished. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: • hives • breathing problem • itching • swelling of the lips, tongue, face • dizziness • wheezing • fainting 2. Sulfite allergic reactions. edaravone injection contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening.

Sodium bisulfite can also cause less severe allergic reactions, for example, asthma episodes, in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: • hives • trouble breathing or swallowing • itching • swelling of the lips, tongue, face • dizziness • asthma attack (in people with asthma) • wheezing • fainting Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.

The most common side effects of edaravone injection include bruising (contusion), problems walking (gait disturbance), and headache. These are not all the possible side effects of edaravone injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or Sandoz Inc. at 1-800-525-8747.

What are the ingredients in edaravone injection? Active ingredient: edaravone Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide. Manufactured by InfoRLife SA for Sandoz Inc., Princeton, NJ 08540 This Patient Information has been approved by the U.S.

Food and Drug Administration Revised: 10/2023

📄 Package Label / Principal Display Panel 83 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0781-3527-20 Edaravone Injection 30 mg/100 mL (0.3 mg/mL) For Intravenous Infusion (Infuse each 30 mg/100 mL bag over a period of 30 minutes) Sterile Solution Single-dose - Discard unused portion Rx Only Each 100 mL single-dose bag contains: Active: 30 mg edaravone Inactive: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4. 100 mL x 2 Bags SANDOZ carton

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

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 this package alone, 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.
📅 Q3 2025 – Q4 2025 · 2 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
20
Units reimbursed last 4 qtrs
40
Gross reimbursed last 4 qtrs
$23.6K
Avg / prescription
$1,177.50
Avg / unit
$588.75
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 20 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: 40 units · 2.9 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported 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: no data reported 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: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported 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: no data reported 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: no data reported FL
Units reimbursed · per 100k residents
2.92.9
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 Maine 2.9 /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.

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

Medicare Part D (outpatient prescription) spending for Edaravone — 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 Edaravone. 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
$216.9K
Claims incl. refills
25
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$8,677.28
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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 ✓ 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 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 Sandoz Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sandoz 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 J1301 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.
← 00781-3522-70 · Sandoz 00781-3528-10 · Sandoz →
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.