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United States · US · US:70594-066_49c340b4-c825-4e34-adcf-f49be55ec2a6
Daptomycin
Orange BookUNIISPLATC J01XX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXellia Pharmaceuticals USA LLC
CountryUS (United States)
ATC codeJ01XX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170594066011 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
N217415
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "NWQ5N31VKK",
"rxcui": "22299",
"inchikey": "DOAKLVKFURWEDJ-QCMAZARJSA-N",
"display_name": "DAPTOMYCIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"1957b6ce-7382-4a7b-bf02-3595948d09c6": {
"match": "brand_token",
"title": "DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]",
"spl_version": "6",
"published_date": "2026-05-12"
}
},
"productid": "70594-066_49c340b4-c825-4e34-adcf-f49be55ec2a6",
"productndc": "70594-066",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217415",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "350MG/VIAL",
"product_no": "001",
"approval_date": "Jan 30, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/VIAL",
"product_no": "002",
"approval_date": "Jan 30, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPTOMYCIN",
"proprietary_name": "Daptomycin",
"active_ingred_unit": "mg/7mL",
"application_number": "NDA217415",
"marketing_category": "NDA",
"nonproprietary_name": "daptomycin",
"start_marketing_date": "20231103",
"active_numerator_strength": "350"
}Related drugs
Other records sharing ATC code J01XX09.
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