Prescription drug · ANDA
Riluzole NDC 62756-538
Riluzole 50 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-538-18 | 62756053818 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18)Marketed from Jun 18, 2013 | |
| 62756-538-83 | 62756053883 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83)Marketed from Jun 18, 2013 | |
| 62756-538-86 | 62756053886 | 60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86)Marketed from Jun 18, 2013 | |
| 62756-538-88 | 62756053888 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)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
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091417
- Marketing start
- Listing expires
- Other FDA classes
- Benzothiazoles (Chemical structure)
- Identifiers
- Product ID 62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2SPL ID 9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2SPL set ID 4c851be4-f0d0-4b24-baf9-427ddfc6f7b0RxCUI 199206UNII 7LJ087RS6FUPC 0362756538832
- 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
N462756053818followed by a unit qualifier and the quantityPackage 62756-0538-18. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 62756-538
- What is NDC 62756-538?
- 62756-538 is the product NDC for Riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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.
Related NDCs: other Riluzole products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Glenmark Pharmaceuticals Inc., USA | 68462-381 | 68462-0381-1068462-0381-60 |