Rizafilm
NDC Package 35781-0605-8
Package Information
Rizafilm (rizatriptan benzoate) films is rizatriptan is used to treat migraines. This formulation utilizes a film delivery system. Marketed by Gensco Laboratories Llc, this product is identified by NDC 35781-0605 and is authorized under FDA application NDA205394.
Identification & Billing
- RxCUI: 2634482 - rizatriptan 10 MG Oral Film
- RxCUI: 2634482 - rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Film
- RxCUI: 2634489 - rizatriptan 5 MG Oral Film
- RxCUI: 2634489 - rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG)Oral Film
- RxCUI: 2672955 - RizaFilm 10 MG Oral Film
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 35781 - Gensco Laboratories Llc
- 35781-0605 - Rizafilm
- 35781-0605-8 - 18 POUCH in 1 CARTON / 1 FILM in 1 POUCH (35781-0605-1)
- 35781-0605 - Rizafilm
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 35781-0605-8 identifies a specific commercial package of 18 pouch in 1 carton / 1 film in 1 pouch (35781-0605-1) of Rizafilm, a human prescription drug labeled by Gensco Laboratories Llc. This film is formulated for oral use and contains rizatriptan benzoate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gensco Laboratories Llc on April 27, 2026. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Rizatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Rizatriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Rizatriptan does not prevent future migraines or lessen how often you get migraine attacks.
How is this Gensco Laboratories Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 35781060508. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.