🇺🇸
United States · US · US:0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6
MAXITROL
Orange BookUNIISPLATC A01AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeA01AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100780771013.5 g in 1 TUBE (0078-0771-01)
Annotations
UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N050065
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": {
"ecfb954f-5554-0ad2-e053-2995a90a7516": {
"match": "brand_token",
"title": "MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [HARROW EYE, LLC]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6",
"productndc": "0078-0771",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "050065",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"proprietary_name": "MAXITROL",
"active_ingred_unit": "mg/g; mg/g; [USP'U]/g",
"application_number": "NDA050065",
"marketing_category": "NDA",
"nonproprietary_name": "neomycin sulfate, polymyxin b sulfate and dexamethasone",
"start_marketing_date": "19720117",
"active_numerator_strength": "1; 3.5; 10000"
}Related drugs
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