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United States · US · US:71839-108_9b7e93ce-5bc1-4018-85cc-9746ce516e69
daptomycin
Orange BookUNIISPLATC J01XX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBE Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1171839108011 VIAL in 1 CARTON (71839-108-01) / 7 mL in 1 VIAL
- ndc11718391081010 VIAL in 1 CARTON (71839-108-10) / 7 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
A213425
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": "71839-108_9b7e93ce-5bc1-4018-85cc-9746ce516e69",
"productndc": "71839-108",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "213425",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "350MG/VIAL",
"product_no": "001",
"approval_date": "Aug 20, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPTOMYCIN",
"proprietary_name": "daptomycin",
"active_ingred_unit": "mg/7mL",
"application_number": "ANDA213425",
"marketing_category": "ANDA",
"nonproprietary_name": "daptomycin",
"start_marketing_date": "20200820",
"active_numerator_strength": "350"
}Related drugs
Other records sharing ATC code J01XX09.
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