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United States · US · US:25021-196_1d99f0e9-015c-4be1-b110-bdd156846dd1
Polymyxin B
Orange BookUNIISPLATC J01XB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ01XB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250211961010 VIAL in 1 CARTON (25021-196-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A207322
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": "25021-196_1d99f0e9-015c-4be1-b110-bdd156846dd1",
"productndc": "25021-196",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "207322",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500,000 UNITS BASE/VIAL",
"product_no": "001",
"approval_date": "Apr 14, 2016"
}
],
"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": "ANDA207322",
"marketing_category": "ANDA",
"nonproprietary_name": "Polymyxin B Sulfate",
"start_marketing_date": "20251001",
"active_numerator_strength": "500000"
}Related drugs
Other records sharing ATC code J01XB02.
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