FDA.reportPublic FDA data

RIZAFILM

Product NDC
35781-0605
11-digit product format
357810605
Labeler code
35781
Product ID
35781-0605_33c5d784-a42c-4b10-e063-6394a90a9b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
FILM
Route
ORAL
Labeler
Gensco Laboratories LLC
Application
NDA205394
Marketing category
NDA
Marketing start
2026-04-27
Substance
RIZATRIPTAN BENZOATE
Active strength
5 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RIZAFILM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui2634482, 2634489, 2672955

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
8b537454-32b8-7e64-1395-258682782d07Product name520170424
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0605-1RIZAFILM1 in 1 POUCHFILM15
35781-0605-8RIZAFILM18 in 1 CARTONFILM185

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672955RizaFilm 10 MG Oral FilmPSNfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634482rizatriptan 10 MG Oral FilmPSNfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634489rizatriptan 5 MG Oral FilmPSNfa32794e-d26d-e0bf-e053-6294a90abb0e5
2672955rizatriptan 10 MG Oral Film [Rizafilm]SBDfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634482rizatriptan 10 MG Oral FilmSCDfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634489rizatriptan 5 MG Oral FilmSCDfa32794e-d26d-e0bf-e053-6294a90abb0e5
2672955RizaFilm 10 MG (as rizatriptan benzoate 14.53 MG) Oral FilmSYfa32794e-d26d-e0bf-e053-6294a90abb0e5
2672955Rizafilm 10 MG Oral FilmSYfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634482rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral FilmSYfa32794e-d26d-e0bf-e053-6294a90abb0e5
2634489rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG)Oral FilmSYfa32794e-d26d-e0bf-e053-6294a90abb0e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35781-0605-1357810605011 in 1 POUCHHistorical
35781-0605-83578106050818 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1) 18 pouch2026-04-27NoNoHistorical