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United States · US · US:35781-0605_33c5d784-a42c-4b10-e063-6394a90a9b81
RIZAFILM
Orange BookUNIISPLATC N02CC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGensco Laboratories LLC
CountryUS (United States)
ATC codeN02CC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11357810605818 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1)
Annotations
UNII (FDA Substance ID)
WR978S7QHH
RIZATRIPTAN BENZOATE
RxCUI 237082
Orange Book
N205394
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WR978S7QHH",
"rxcui": "237082",
"inchikey": "JPRXYLQNJJVCMZ-UHFFFAOYSA-N",
"display_name": "RIZATRIPTAN BENZOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fa32794e-d26d-e0bf-e053-6294a90abb0e": {
"match": "brand_token",
"title": "RIZAFILM (RIZATRIPTAN BENZOATE) FILM [GENSCO LABORATORIES LLC]",
"spl_version": "5",
"published_date": "2026-04-27"
}
},
"productid": "35781-0605_33c5d784-a42c-4b10-e063-6394a90a9b81",
"productndc": "35781-0605",
"dosage_form": "FILM",
"orange_book": {
"appl_no": "205394",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Apr 14, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Feb 26, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIZATRIPTAN BENZOATE",
"proprietary_name": "RIZAFILM",
"active_ingred_unit": "mg/1",
"application_number": "NDA205394",
"marketing_category": "NDA",
"nonproprietary_name": "rizatriptan benzoate",
"start_marketing_date": "20260427",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N02CC04.
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