🇺🇸
United States · US · US:0338-0714_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3
Daptomycin in Sodium Chloride
Orange BookUNIISPLATC J01XX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeJ01XX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11033807142424 BAG in 1 CARTON (0338-0714-24) / 50 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
N213645
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": "0338-0714_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3",
"productndc": "0338-0714",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213645",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jan 25, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "350MG/50ML (7MG/ML)",
"product_no": "002",
"approval_date": "Feb 27, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/50ML (10MG/ML)",
"product_no": "003",
"approval_date": "Feb 27, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "700MG/100ML (7MG/ML)",
"product_no": "004",
"approval_date": "Feb 27, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1GM/100ML (10MG/ML)",
"product_no": "005",
"approval_date": "Feb 27, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAPTOMYCIN",
"proprietary_name": "Daptomycin in Sodium Chloride",
"active_ingred_unit": "mg/50mL",
"application_number": "NDA213645",
"marketing_category": "NDA",
"nonproprietary_name": "Daptomycin in Sodium Chloride",
"start_marketing_date": "20220125",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01XX09.
Access this data programmatically
Query Daptomycin in Sodium Chloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.