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United States · US · US:0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31
TOBREX
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100780813013.5 g in 1 TUBE (0078-0813-01)
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
N050555
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tobramycin Solution
Raw payload (JSON)
{
"unii": {
"unii": "VZ8RRZ51VK",
"rxcui": "10627",
"inchikey": "NLVFBUXFDBBNBW-PBSUHMDJSA-N",
"display_name": "TOBRAMYCIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"5b66bba3-cf97-4a9c-b618-ba5f277f20f6": {
"match": "brand_token",
"title": "TOBREX (TOBRAMYCIN) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "6",
"published_date": "2025-12-18"
}
},
"productid": "0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31",
"productndc": "0078-0813",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "050555",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "TOBREX",
"active_ingred_unit": "mg/g",
"application_number": "NDA050555",
"marketing_category": "NDA",
"nonproprietary_name": "tobramycin",
"start_marketing_date": "19810628",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code J01GB01.
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