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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

  • ndc11
    7183910801
    1 VIAL in 1 CARTON (71839-108-01) / 7 mL in 1 VIAL
  • ndc11
    7183910810
    10 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

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