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United States · US · US:63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
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
- ndc11633233211010 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A065372
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; OPHTHALMIC",
"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": "63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82",
"productndc": "63323-321",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "065372",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500,000 UNITS BASE/VIAL",
"product_no": "001",
"approval_date": "Jan 10, 2008"
}
],
"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": "ANDA065372",
"marketing_category": "ANDA",
"nonproprietary_name": "POLYMYXIN B SULFATE",
"start_marketing_date": "20091117",
"active_numerator_strength": "500000"
}Related drugs
Other records sharing ATC code J01XB02.
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