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United States · US · US:60923-227_f388df1b-13aa-4b95-a7fa-9694dc86981c
AMONDYS 45
Orange BookUNIISPLATC M09AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSarepta Therapeutics, Inc.
CountryUS (United States)
ATC codeM09AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160923227021 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) / 2 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
X8UHF7SX0R
CASIMERSEN
RxCUI 2480096
Orange Book
N213026
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X8UHF7SX0R",
"rxcui": "2480096",
"inchikey": null,
"display_name": "CASIMERSEN",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"e9e5fd44-eeda-4580-bba1-a734828bbcc3": {
"match": "brand_token",
"title": "AMONDYS 45 (CASIMERSEN) INJECTION [SAREPTA THERAPEUTICS, INC.]",
"spl_version": "11",
"published_date": "2026-02-25"
}
},
"productid": "60923-227_f388df1b-13aa-4b95-a7fa-9694dc86981c",
"productndc": "60923-227",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "213026",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/2ML (50MG/ML)",
"product_no": "001",
"approval_date": "Feb 25, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CASIMERSEN",
"proprietary_name": "AMONDYS 45",
"active_ingred_unit": "mg/mL",
"application_number": "NDA213026",
"marketing_category": "NDA",
"nonproprietary_name": "casimersen",
"start_marketing_date": "20210225",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code M09AX13.
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