🇺🇸
United States · US · US:68788-8748_eb89e778-f8f3-40f2-9506-62f00128ad08
Neomycin and Polymyxin B Sulfates and Dexamethasone
Orange BookUNIISPLATC A01AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA01AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788874831 TUBE in 1 CARTON (68788-8748-3) / 3.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A064063
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": "68788-8748_eb89e778-f8f3-40f2-9506-62f00128ad08",
"productndc": "68788-8748",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "064063",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM",
"product_no": "001",
"approval_date": "Jul 25, 1994"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"proprietary_name": "Neomycin and Polymyxin B Sulfates and Dexamethasone",
"active_ingred_unit": "mg/g; mg/g; [USP'U]/g",
"application_number": "ANDA064063",
"marketing_category": "ANDA",
"nonproprietary_name": "Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone",
"start_marketing_date": "20241011",
"active_numerator_strength": "1; 3.5; 10000"
}Related drugs
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