Prescription drug · ANDA
Riluzole NDC 69076-200
Riluzole 50 mg/1 · Tablet, Film coated · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69076-200-60 | 6907602006069076020060 | 60 TABLET, FILM COATED in 1 BOTTLE (69076-200-60)Marketed from Jan 1, 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
- Florida Pharmaceutical Products, LLCNDC labeler code 69076
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206045
- Marketing start
- Listing expires
- Other FDA classes
- Benzothiazoles (Chemical structure)
- Identifiers
- Product ID 69076-200_5daced17-3253-0b11-e063-6394a90a252aSPL ID 5daced17-3253-0b11-e063-6394a90a252a
- 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
N469076020060followed by a unit qualifier and the quantityPackage 69076-0200-60. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69076-200
- What is NDC 69076-200?
- 69076-200 is the product NDC for Riluzole, Riluzole 50 mg/1 tablet, film coated, listed with the FDA by Florida Pharmaceutical Products, LLC. 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?
- Florida Pharmaceutical Products, LLC, NDC labeler code 69076. 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 | 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.