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United States · US · US:67184-0549_77549b99-ead5-4148-a1b1-e1b66e9da5ea

Daptomycin

Orange BookUNIISPLATC J01XX09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeJ01XX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6718405491
    1 VIAL, SINGLE-USE in 1 CARTON (67184-0549-1) / 10 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
A215316
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": "67184-0549_77549b99-ead5-4148-a1b1-e1b66e9da5ea",
  "productndc": "67184-0549",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215316",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 24, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPTOMYCIN",
  "proprietary_name": "Daptomycin",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA215316",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Daptomycin",
  "start_marketing_date": "20210824",
  "active_numerator_strength": "500"
}

Related drugs

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