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United States · US · US:25021-179_4245fbb1-e161-4c27-93b6-6afb59618099

Daptomycin

Orange BookUNIISPLATC J01XX09

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ01XX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2502117915
    1 VIAL in 1 CARTON (25021-179-15) / 7 mL in 1 VIAL
  • ndc11
    2502117916
    10 VIAL in 1 CARTON (25021-179-16) / 7 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
NWQ5N31VKK
DAPTOMYCIN
RxCUI 22299
Orange Book
N208385
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": "25021-179_4245fbb1-e161-4c27-93b6-6afb59618099",
  "productndc": "25021-179",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208385",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "350MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 12, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPTOMYCIN",
  "proprietary_name": "Daptomycin",
  "active_ingred_unit": "mg/7mL",
  "application_number": "NDA208385",
  "marketing_category": "NDA",
  "nonproprietary_name": "Daptomycin",
  "start_marketing_date": "20180115",
  "active_numerator_strength": "350"
}

Related drugs

Other records sharing ATC code J01XX09.

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