Prescription drug · NDA
Tiglutik (Riluzole) NDC 11797-210
Riluzole 50 mg/10mL · Suspension · Oral · Italfarmaco SPA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11797-210-01 | 11797021001 | 2 BOTTLE, PLASTIC in 1 CARTON (11797-210-01) / 300 mL in 1 BOTTLE, PLASTICMarketed from Sep 21, 2018 |
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)
- Tiglutik
- Generic name (nonproprietary)
- riluzole
- Active ingredients
- Riluzole — 50 mg/10mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Italfarmaco SPANDC labeler code 11797
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209080
- Marketing start
- Listing expires
- Other FDA classes
- Benzothiazoles (Chemical structure)
- Identifiers
- Product ID 11797-210_2ba33fab-05a6-42db-9b4a-277bb3a30f29SPL ID 2ba33fab-05a6-42db-9b4a-277bb3a30f29SPL set ID 20b7165a-eb4d-42a0-b2d8-16eff90a214eRxCUI 2058147, 2059266UNII 7LJ087RS6F
- 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
N411797021001followed by a unit qualifier and the quantityPackage 11797-0210-01. 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 .
About NDC 11797-210
- What is NDC 11797-210?
- 11797-210 is the product NDC for Tiglutik (riluzole), Riluzole 50 mg/10mL suspension, listed with the FDA by Italfarmaco SPA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tiglutik (Riluzole).
- What is the active ingredient?
- Riluzole.
- Who is the labeler?
- Italfarmaco SPA, NDC labeler code 11797. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tiglutik?
- 1 other product NDC are listed under this name. See all Tiglutik NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tiglutik products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tiglutikriluzole | Riluzole 50 mg/10mL | LiquidOral | EDW PHARMA, INC | 70726-0303 | 70726-0303-01 |
Other NDCs under NDA 209080
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tiglutikriluzole | Riluzole 50 mg/10mL | LiquidOral | EDW PHARMA, INC | 70726-0303 |