🇺🇸
United States · US · US:0078-0876_11f2ad7a-2b97-4316-84b5-49fee866fa81
TobraDex
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
- ndc1100780876013.5 g in 1 TUBE (0078-0876-01)
Annotations
UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N050616
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": {
"7f310e0e-0d3b-493d-b6c4-238493a2a9b9": {
"match": "brand_token",
"title": "TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "8",
"published_date": "2025-09-29"
}
},
"productid": "0078-0876_11f2ad7a-2b97-4316-84b5-49fee866fa81",
"productndc": "0078-0876",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "050616",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.1%;0.3%",
"product_no": "001",
"approval_date": "Sep 28, 1988"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXAMETHASONE; TOBRAMYCIN",
"proprietary_name": "TobraDex",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "NDA050616",
"marketing_category": "NDA",
"nonproprietary_name": "tobramycin and dexamethasone",
"start_marketing_date": "19881015",
"active_numerator_strength": "1; 3"
}Related drugs
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