Prescription drug · ANDA
Riluzole NDC 67877-286
Riluzole 50 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-286-05 | 67877028605 | 500 TABLET in 1 BOTTLE (67877-286-05)Marketed from Mar 31, 2016 | |
| 67877-286-10 | 67877028610 | 1000 TABLET in 1 BOTTLE (67877-286-10)Marketed from Mar 31, 2016 | |
| 67877-286-14 | 67877028614 | 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACKMarketed from Mar 31, 2016 | |
| 67877-286-60 | 67877028660 | 60 TABLET in 1 BOTTLE (67877-286-60)Marketed from Mar 31, 2016 | |
| 67877-286-90 | 67877028690 | 90 TABLET in 1 BOTTLE (67877-286-90)Marketed from Mar 31, 2016 |
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
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204048
- Marketing start
- Listing expires
- Other FDA classes
- Benzothiazoles (Chemical structure)
- Identifiers
- Product ID 67877-286_ac47b3f7-ac8b-472d-99c6-82b08d7a086fSPL ID ac47b3f7-ac8b-472d-99c6-82b08d7a086fSPL set ID dd432c13-389e-46b3-8891-0cf1a58800ffRxCUI 199206UNII 7LJ087RS6FUPC 0367877286600
- 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
N467877028605followed by a unit qualifier and the quantityPackage 67877-0286-05. 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 .
Indications (excerpt from the label)
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 67877-286
- What is NDC 67877-286?
- 67877-286 is the product NDC for Riluzole, Riluzole 50 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 5 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 | 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 |