What is NDC 68462-381?

68462-381 is the product NDC for riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-381 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-381Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0381Add 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
68462-381-10	68462038110	1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10)Marketed from Jun 18, 2013
68462-381-60	68462038160	60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)Marketed from Jun 18, 2013

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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091394
Marketing start: Jun 18, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Benzothiazoles (Chemical structure)
Identifiers: Product ID 68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6SPL ID e8a81e60-47b6-4097-9e49-48eb88e694f6SPL set ID f1ce57e8-d3fe-422c-8724-3101c258898aRxCUI 199206UNII 7LJ087RS6FUPC 0368462381601
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

N468462038110 followed by a unit qualifier and the quantity

Package 68462-0381-10. 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 Jul 10, 2020.

Indications (excerpt from the label)

Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets are 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 68462-381

What is NDC 68462-381?: 68462-381 is the product NDC for riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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	AvKARE	42291-775	42291-0775-60
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