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United States · US · US:63323-371_7b38aacb-d9c9-47db-a6fe-7e7d938fcd69
Daptomycin
Orange BookUNIISPLATC J01XX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01XX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323371101 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-10) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
A206077
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": "63323-371_7b38aacb-d9c9-47db-a6fe-7e7d938fcd69",
"productndc": "63323-371",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "206077",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Apr 11, 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": "ANDA206077",
"marketing_category": "ANDA",
"nonproprietary_name": "Daptomycin",
"start_marketing_date": "20180411",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01XX09.
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