What is NDC 68083-501?

68083-501 is the product NDC for edaravone, Edaravone 60 mg/100mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0501Add 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
68083-501-01	6808305010168083050101	1 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from May 6, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 60 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216199
Marketing start: May 6, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 68083-501_57566e6e-e90a-4fdf-b23c-d8af19893fd2SPL ID 57566e6e-e90a-4fdf-b23c-d8af19893fd2SPL set ID 46452eb5-db17-400d-b25b-11844a11e711RxCUI 1924316, 2681044UNII 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

N468083050101 followed by a unit qualifier and the quantity

Package 68083-0501-01. 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 May 7, 2024.

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 68083-501

What is NDC 68083-501?: 68083-501 is the product NDC for edaravone, Edaravone 60 mg/100mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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	InjectionIntravenous	Sandoz Inc	0781-3527	00781-3527-20
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

Other NDCs under ANDA 216199

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216199
Product	Strength	Form · route	Labeler	Product NDC
Edaravone	Edaravone 30 mg/100mL	Injection, SolutionIntravenous	Piramal Critical Care Inc.	66794-259
edaravone	Edaravone 30 mg/100mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-500