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United States · US · US:71558-590_9f8bbe4b-d496-41c7-85c6-470f0e83c2d1
ARIKAYCE
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInsmed Incorporated
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11715585902828 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
84319SGC3C
AMIKACIN
RxCUI 641
Orange Book
N207356
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "84319SGC3C",
"rxcui": "641",
"inchikey": "LKCWBDHBTVXHDL-RMDFUYIESA-N",
"display_name": "AMIKACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"499ab990-2b21-474f-aaba-d86388965f40": {
"match": "brand_token",
"title": "ARIKAYCE (AMIKACIN) SUSPENSION [INSMED INCORPORATED]",
"spl_version": "14",
"published_date": "2026-01-16"
}
},
"productid": "71558-590_9f8bbe4b-d496-41c7-85c6-470f0e83c2d1",
"productndc": "71558-590",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "207356",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 590MG BASE/8.4ML",
"product_no": "001",
"approval_date": "Sep 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIKACIN",
"proprietary_name": "ARIKAYCE",
"active_ingred_unit": "mg/8.4mL",
"application_number": "NDA207356",
"marketing_category": "NDA",
"nonproprietary_name": "Amikacin",
"start_marketing_date": "20181012",
"active_numerator_strength": "590"
}Related drugs
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