🇺🇸
United States · US · US:63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56
Polymyxin B Sulfate and Trimethoprim
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187631101 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A064120
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": "63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56",
"productndc": "63187-631",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "064120",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Feb 14, 1997"
}
],
"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": "ANDA064120",
"marketing_category": "ANDA",
"nonproprietary_name": "Polymyxin B Sulfate and Trimethoprim Sulfate",
"start_marketing_date": "19970214",
"active_numerator_strength": "10000; 1"
}Related drugs
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