Prescription drug · NDA
Rizafilm (Rizatriptan benzoate) NDC 35781-0605
Rizatriptan benzoate 5 mg/1 · Film · Oral · Gensco Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35781-0605-8 | 3578106050835781060508 | 18 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1)Marketed from Apr 27, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rizafilm
- Generic name (nonproprietary)
- rizatriptan benzoate
- Active ingredients
- Rizatriptan benzoate — 5 mg/1
- Dosage form
- Film
- Route
- Oral
- Labeler
- Gensco Laboratories LLCNDC labeler code 35781
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205394
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 35781-0605_33c5d784-a42c-4b10-e063-6394a90a9b81SPL ID 33c5d784-a42c-4b10-e063-6394a90a9b81SPL set ID fa32794e-d26d-e0bf-e053-6294a90abb0eRxCUI 2634482, 2634489, 2672955, 2752328UNII WR978S7QHH
- Pharmacologic class
- Serotonin-1b and Serotonin-1d Receptor Agonist
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
N435781060508followed by a unit qualifier and the quantityPackage 35781-0605-08. 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)
RizaFilm™ is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks. RizaFilm is not indicated for the preventive treatment of migraine. Safety and effectiveness of RizaFilm have not been established for cluster headache. RizaFilm is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migrai…
Excerpt only. Read the full label for complete information.
About NDC 35781-0605
- What is NDC 35781-0605?
- 35781-0605 is the product NDC for Rizafilm (rizatriptan benzoate), Rizatriptan benzoate 5 mg/1 film, listed with the FDA by Gensco Laboratories LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rizafilm (Rizatriptan benzoate).
- What is the active ingredient?
- Rizatriptan benzoate.
- Who is the labeler?
- Gensco Laboratories LLC, NDC labeler code 35781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rizafilm?
- 2 other product NDCs are listed under this name. See all Rizafilm NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rizafilm products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rizafilmrizatriptan benzoate | Rizatriptan benzoate 10 mg/1 | FilmOral | Gensco Laboratories LLC | 35781-0600 | 35781-0600-08 |
| Rizafilmrizatriptan benzoate | Rizatriptan benzoate 10 mg/1 | FilmOral | A-S Medication Solutions | 50090-8038 | 50090-8038-0050090-8038-01 |
Other NDCs under NDA 205394
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 |
|---|---|---|---|---|
| Rizafilmrizatriptan benzoate | Rizatriptan benzoate 10 mg/1 | FilmOral | Gensco Laboratories LLC | 35781-0600 |
| Rizafilmrizatriptan benzoate | Rizatriptan benzoate 10 mg/1 | FilmOral | A-S Medication Solutions | 50090-8038 |