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United States · US · US:63323-306_c55fcee9-70c7-4926-bee6-014c0b133249
Tobramycin
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633233060225 VIAL, MULTI-DOSE in 1 TRAY (63323-306-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-306-01)
- ndc11633233063010 VIAL, MULTI-DOSE in 1 TRAY (63323-306-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-306-05)
Annotations
UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A065122
APAP
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": "INTRAMUSCULAR; 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": "63323-306_c55fcee9-70c7-4926-bee6-014c0b133249",
"productndc": "63323-306",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "065122",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Nov 29, 2002"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/ML",
"product_no": "002",
"approval_date": "Nov 29, 2002"
}
],
"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": "ANDA065122",
"marketing_category": "ANDA",
"nonproprietary_name": "TOBRAMYCIN SULFATE",
"start_marketing_date": "20051123",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code J01GB01.
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