🇺🇸
United States · US · US:61314-628_4d36bcb4-0517-40ad-8c6e-74ca25ddae74
Polymyxin B Sulfate and Trimethoprim
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11613146281010 mL in 1 BOTTLE, PLASTIC (61314-628-10)
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A064211
AT
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": "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": "61314-628_4d36bcb4-0517-40ad-8c6e-74ca25ddae74",
"productndc": "61314-628",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "064211",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AT",
"strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 13, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
"proprietary_name": "Polymyxin B Sulfate and Trimethoprim",
"active_ingred_unit": "[USP'U]/mL; mg/mL",
"application_number": "ANDA064211",
"marketing_category": "ANDA",
"nonproprietary_name": "Polymyxin B Sulfate and Trimethoprim",
"start_marketing_date": "19980416",
"active_numerator_strength": "10000; 1"
}Related drugs
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