🇺🇸
United States · US · US:70594-023_89aaab5f-68ab-4848-b9c6-a4e1051aaf4c
Colistimethate
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXellia Pharmaceuticals USA LLC
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170594023091 VIAL in 1 CARTON (70594-023-09) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
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": "70594-023_89aaab5f-68ab-4848-b9c6-a4e1051aaf4c",
"productndc": "70594-023",
"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": "20220220",
"active_numerator_strength": "150"
}Related drugs
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