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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

  • ndc11
    0338071424
    24 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        "strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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

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