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United States · US · US:60923-284_97565339-f295-43ab-98a9-bb6bdf2d049c
Exondys 51
Orange BookUNIISPLATC M09AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSarepta Therapeutics, Inc.
CountryUS (United States)
ATC codeM09AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160923284101 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
AIW6036FAS
ETEPLIRSEN
RxCUI 1810569
Orange Book
N206488
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "AIW6036FAS",
"rxcui": "1810569",
"inchikey": null,
"display_name": "ETEPLIRSEN",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"33bff678-7829-479e-9110-b8e33a0bc0aa": {
"match": "brand_token",
"title": "EXONDYS 51 (ETEPLIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.]",
"spl_version": "15",
"published_date": "2025-08-20"
}
},
"productid": "60923-284_97565339-f295-43ab-98a9-bb6bdf2d049c",
"productndc": "60923-284",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "206488",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/2ML (50MG/ML)",
"product_no": "001",
"approval_date": "Sep 19, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/10ML (50MG/ML)",
"product_no": "002",
"approval_date": "Sep 19, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETEPLIRSEN",
"proprietary_name": "Exondys 51",
"active_ingred_unit": "mg/mL",
"application_number": "NDA206488",
"marketing_category": "NDA",
"nonproprietary_name": "eteplirsen",
"start_marketing_date": "20160919",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code M09AX06.
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