🇺🇸
United States · US · US:68071-4375_1a555d03-b3db-da48-e063-6394a90a7576
Neomycin Polymyxin B Sulfates and Dexamethasone
Orange BookUNIISPLATC A01AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA01AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168071437555 mL in 1 BOX (68071-4375-5)
Annotations
UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A064135
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7S5I7G3JQL",
"rxcui": "3264",
"inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
"display_name": "DEXAMETHASONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"a2f47d77-efd3-4c84-a364-08fb6d9978eb": {
"match": "brand_token",
"title": "NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]",
"spl_version": "18",
"published_date": "2026-05-21"
}
},
"productid": "68071-4375_1a555d03-b3db-da48-e063-6394a90a7576",
"productndc": "68071-4375",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "064135",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML",
"product_no": "001",
"approval_date": "Sep 13, 1995"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"proprietary_name": "Neomycin Polymyxin B Sulfates and Dexamethasone",
"active_ingred_unit": "mg/mL; mg/mL; [USP'U]/mL",
"application_number": "ANDA064135",
"marketing_category": "ANDA",
"nonproprietary_name": "Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone",
"start_marketing_date": "19950913",
"active_numerator_strength": "1; 3.5; 10000"
}Related drugs
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