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United States · US · US:64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0
SKYCLARYS
Orange BookUNIISPLATC N07XX25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiogen
CountryUS (United States)
ATC codeN07XX25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11644062509090 CAPSULE in 1 BOTTLE (64406-250-90)
Annotations
UNII (FDA Substance ID)
G69Z98951Q
OMAVELOXOLONE
Orange Book
N216718
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G69Z98951Q",
"rxcui": null,
"inchikey": "RJCWBNBKOKFWNY-IDPLTSGASA-N",
"display_name": "OMAVELOXOLONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2709e870-df3d-f30f-e063-6394a90aeda1": {
"match": "brand_token",
"title": "SKYCLARYS (OMAVELOXOLONE) CAPSULE [BIOGEN]",
"spl_version": "9",
"published_date": "2026-04-17"
}
},
"productid": "64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0",
"productndc": "64406-250",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "216718",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Feb 28, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMAVELOXOLONE",
"proprietary_name": "SKYCLARYS",
"active_ingred_unit": "mg/1",
"application_number": "NDA216718",
"marketing_category": "NDA",
"nonproprietary_name": "omaveloxolone",
"start_marketing_date": "20230228",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N07XX25.
- ISSiiltibcySerum Life Science Europe GmbH
- ISSkyclarysBiogen Netherlands B.V.
- FISkyclarysBiogen Netherlands B.V.
- 🇨🇭SkyclarysBiogen Switzerland AG
- DKSkyclarysBiogen Netherlands B.V.
- CZSKYCLARYSBiogen Netherlands B.V., Badhoevedorp
- CZSKYCLARYSBiogen Netherlands B.V., Badhoevedorp
- BESkyclarys 50 mgBiogen Netherlands
Access this data programmatically
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