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United States · US · US:23155-193_698b0d4f-1182-475f-aafb-bfcbd0b637f2

COLISTIMETHATE SODIUM

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2315519331
    1 VIAL, GLASS in 1 CARTON (23155-193-31) / 4 mL in 1 VIAL, GLASS
  • ndc11
    2315519341
    12 VIAL, GLASS in 1 CARTON (23155-193-41) / 4 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
XW0E5YS77G
COLISTIMETHATE SODIUM
RxCUI 48305
Orange Book
A202359
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XW0E5YS77G",
    "rxcui": "48305",
    "inchikey": null,
    "display_name": "COLISTIMETHATE SODIUM",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "8ec7dc90-825c-422e-9f4b-c8ace9d93af5": {
      "match": "brand_token",
      "title": "COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]",
      "spl_version": "5",
      "published_date": "2026-04-09"
    }
  },
  "productid": "23155-193_698b0d4f-1182-475f-aafb-bfcbd0b637f2",
  "productndc": "23155-193",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 150MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLISTIMETHATE SODIUM",
  "proprietary_name": "COLISTIMETHATE SODIUM",
  "active_ingred_unit": "mg/4mL",
  "application_number": "ANDA202359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "COLISTIMETHATE SODIUM",
  "start_marketing_date": "20210909",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code A07AA.

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