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United States · US · US:60923-465_5fbaac76-f7cb-4f43-99f8-af43c2655ff0
Vyondys 53
Orange BookUNIISPLATC M09AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSarepta Therapeutics, Inc.
CountryUS (United States)
ATC codeM09AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160923465021 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) / 2 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
033072U4MZ
GOLODIRSEN
RxCUI 2267207
Orange Book
N211970
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "033072U4MZ",
"rxcui": "2267207",
"inchikey": null,
"display_name": "GOLODIRSEN",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5": {
"match": "brand_token",
"title": "VYONDYS 53 (GOLODIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.]",
"spl_version": "16",
"published_date": "2025-07-08"
}
},
"productid": "60923-465_5fbaac76-f7cb-4f43-99f8-af43c2655ff0",
"productndc": "60923-465",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "211970",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/2ML (50MG/ML)",
"product_no": "001",
"approval_date": "Dec 12, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GOLODIRSEN",
"proprietary_name": "Vyondys 53",
"active_ingred_unit": "mg/mL",
"application_number": "NDA211970",
"marketing_category": "NDA",
"nonproprietary_name": "golodirsen",
"start_marketing_date": "20191212",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code M09AX08.
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