What is NDC 0781-3527?

0781-3527 is the product NDC for Edaravone, Edaravone 30 mg/100mL injection, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Edaravone?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Edaravone NDC 0781-3527 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3527Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3527Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0781-3527-20	00781352720	2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94)Marketed from Jan 21, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Edaravone
Generic name (nonproprietary): edaravone
Active ingredients: Edaravone — 30 mg/100mL
Dosage form: Injection
Route: Intravenous
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216902
Marketing start: Jan 21, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39aSPL ID ae940bc6-1e6a-4b76-825c-bd2e1925e39aSPL set ID ae940bc6-1e6a-4b76-825c-bd2e1925e39aRxCUI 1924316UNII S798V6YJRP

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400781352720 followed by a unit qualifier and the quantity

Package 00781-3527-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 1, 2023.

Indications (excerpt from the label)

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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3527

What is NDC 0781-3527?: 0781-3527 is the product NDC for Edaravone, Edaravone 30 mg/100mL injection, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Edaravone.
What is the active ingredient?: Edaravone.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Edaravone?: 3 other product NDCs are listed under this name. See all Edaravone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Edaravone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Edaravone	Edaravone 30 mg/100mL	Injection, SolutionIntravenous	Piramal Critical Care Inc.	66794-259	66794-0259-64
edaravone	Edaravone 30 mg/100mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-500	68083-0500-02
edaravone	Edaravone 60 mg/100mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-501	68083-0501-01