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United States · US · US:0143-9443_a6b19fc2-67bd-4f3d-bcfa-155aeb0d4aca

Colistimethate

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0143944301
    1 VIAL, GLASS in 1 CARTON (0143-9443-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    0143944312
    12 VIAL, GLASS in 1 CARTON (0143-9443-12) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
XW0E5YS77G
COLISTIMETHATE SODIUM
RxCUI 48305
Orange Book
A205356
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": "0143-9443_a6b19fc2-67bd-4f3d-bcfa-155aeb0d4aca",
  "productndc": "0143-9443",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 150MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLISTIMETHATE SODIUM",
  "proprietary_name": "Colistimethate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Colistimethate Sodium",
  "start_marketing_date": "20260304",
  "active_numerator_strength": "150"
}

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