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United States · US · US:63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3
Polymyxin B
Orange BookUNIISPLATC J01XB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01XB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633233674410 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41)
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A202766
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "19371312D4",
"rxcui": "388",
"inchikey": null,
"display_name": "POLYMYXIN B SULFATE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"spl_meta": {
"31a7ad1f-3f58-41a0-94f0-36674285bb61": {
"match": "brand_token",
"title": "POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2026-03-04"
}
},
"productid": "63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3",
"productndc": "63323-367",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "202766",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 500,000 UNITS BASE/VIAL",
"product_no": "001",
"approval_date": "Jan 15, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLYMYXIN B SULFATE",
"proprietary_name": "Polymyxin B",
"active_ingred_unit": "[USP'U]/1",
"application_number": "ANDA202766",
"marketing_category": "ANDA",
"nonproprietary_name": "Polymyxin B Sulfate",
"start_marketing_date": "20150909",
"active_numerator_strength": "500000"
}Related drugs
Other records sharing ATC code J01XB02.
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