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United States · US · US:68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5
Tobramycin
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083241011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-241-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
Annotations
UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A209346
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tobramycin Solution
Raw payload (JSON)
{
"unii": {
"unii": "HJT0RXD7JK",
"rxcui": "7276",
"inchikey": "NZKFUBQRAWPZJP-BXKLGIMVSA-N",
"display_name": "TOBRAMYCIN SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"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": "68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5",
"productndc": "68083-241",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209346",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/ML",
"product_no": "001",
"approval_date": "Feb 9, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN SULFATE",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "Tobramycin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209346",
"marketing_category": "ANDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20210209",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code J01GB01.
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