What is NDC 42291-775?

42291-775 is the product NDC for Riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Riluzole?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Riluzole NDC 42291-775 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-775Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0775Add 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
42291-775-60	42291077560	60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)Marketed from Oct 7, 2020

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): Riluzole
Generic name (nonproprietary): riluzole
Active ingredients: Riluzole — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206045
Marketing start: Oct 7, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Benzothiazoles (Chemical structure)
Identifiers: Product ID 42291-775_4c362542-247a-50f1-e063-6394a90a5065SPL ID 4c362542-247a-50f1-e063-6394a90a5065SPL set ID b117b981-476c-f9b8-e053-2995a90aee5fRxCUI 199206UNII 7LJ087RS6FUPC 0342291775602
Pharmacologic class: Benzothiazole

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442291077560 followed by a unit qualifier and the quantity

Package 42291-0775-60. 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 Mar 4, 2026.

Indications (excerpt from the label)

Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets 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 42291-775

What is NDC 42291-775?: 42291-775 is the product NDC for Riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Riluzole.
What is the active ingredient?: Riluzole.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Riluzole?: 4 other product NDCs are listed under this name. See all Riluzole 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 Riluzole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Riluzole	Riluzole 50 mg/1	Tablet, Film coatedOral	Florida Pharmaceutical Products, LLC	69076-200	69076-0200-60
Riluzole	Riluzole 50 mg/1	TabletOral	Ascend Laboratories, LLC	67877-286	67877-0286-0567877-0286-1067877-0286-14+2 more
Riluzole	Riluzole 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-538	62756-0538-1862756-0538-8362756-0538-86+1 more
riluzole	Riluzole 50 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-381	68462-0381-1068462-0381-60

Other NDCs under ANDA 206045

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

FDA NDC Directory listings under ANDA 206045
Product	Strength	Form · route	Labeler	Product NDC
Riluzole	Riluzole 50 mg/1	Tablet, Film coatedOral	Florida Pharmaceutical Products, LLC	69076-200