Back to search
🇺🇸

United States · US · US:70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952

Kimyrsa

Orange BookUNIISPLATC J01XA05

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

Identification

ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ01XA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7084222501
    1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
VL1P93MKZN
ORITAVANCIN DIPHOSPHATE
RxCUI 1549827
Orange Book
N214155
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VL1P93MKZN",
    "rxcui": "1549827",
    "inchikey": "PWTROOMOPLCZHB-BHYQHFGMSA-N",
    "display_name": "ORITAVANCIN DIPHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5e755c40-6e73-4572-b474-4d8a131693d1": {
      "match": "brand_token",
      "title": "KIMYRSA (ORITAVANCIN DIPHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
      "spl_version": "7",
      "published_date": "2025-12-22"
    }
  },
  "productid": "70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952",
  "productndc": "70842-225",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214155",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.2GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 12, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ORITAVANCIN DIPHOSPHATE",
  "proprietary_name": "Kimyrsa",
  "active_ingred_unit": "mg/40mL",
  "application_number": "NDA214155",
  "marketing_category": "NDA",
  "nonproprietary_name": "oritavancin diphosphate",
  "start_marketing_date": "20210323",
  "active_numerator_strength": "1200"
}

Related drugs

Other records sharing ATC code J01XA05.

Access this data programmatically

Query Kimyrsa 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.