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United States · US · US:67457-813_c32c2064-dd66-4c7f-a35b-c98048a4d3d2
daptomycin
Orange BookUNIISPLATC J01XX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeJ01XX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457813501 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
A205037
AP
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": "67457-813_c32c2064-dd66-4c7f-a35b-c98048a4d3d2",
"productndc": "67457-813",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "205037",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Jun 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPTOMYCIN",
"proprietary_name": "daptomycin",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA205037",
"marketing_category": "ANDA",
"nonproprietary_name": "daptomycin",
"start_marketing_date": "20180904",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01XX09.
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