🇺🇸
United States · US · US:61314-647_e7d4aa10-eff7-4523-9fa2-a60e19e8dee2
Tobramycin and Dexamethasone
Orange BookUNIISPLATC A01AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA01AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1161314647051 BOTTLE in 1 CARTON (61314-647-05) / 5 mL in 1 BOTTLE
- ndc1161314647101 BOTTLE in 1 CARTON (61314-647-10) / 10 mL in 1 BOTTLE
- ndc1161314647251 BOTTLE in 1 CARTON (61314-647-25) / 2.5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N050592
AB
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": {
"1884ef6f-a60c-4a82-a7dc-fd48b7176db0": {
"match": "brand_token",
"title": "TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-06-01"
}
},
"productid": "61314-647_e7d4aa10-eff7-4523-9fa2-a60e19e8dee2",
"productndc": "61314-647",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "050592",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.1%;0.3%",
"product_no": "001",
"approval_date": "Aug 18, 1988"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXAMETHASONE; TOBRAMYCIN",
"proprietary_name": "Tobramycin and Dexamethasone",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA050592",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Tobramycin and Dexamethasone",
"start_marketing_date": "20090102",
"active_numerator_strength": "1; 3"
}Related drugs
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