🇺🇸
United States · US · US:70518-4381_396b50c4-6ca8-360c-e063-6394a90a263d
polymyxin b sulfate and trimethoprim sulfate
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170518438101 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A211572
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": "70518-4381_396b50c4-6ca8-360c-e063-6394a90a263d",
"productndc": "70518-4381",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "211572",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Aug 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLYMYXIN B SULFATE; TRIMETHOPRIM",
"proprietary_name": "polymyxin b sulfate and trimethoprim sulfate",
"active_ingred_unit": "[iU]/mL; mg/mL",
"application_number": "ANDA211572",
"marketing_category": "ANDA",
"nonproprietary_name": "polymyxin b sulfate and trimethoprim sulfate",
"start_marketing_date": "20250701",
"active_numerator_strength": "10000; 1"
}Related drugs
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