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United States · US · US:39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2
Tobramycin
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1139822041211 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL
- ndc1139822041266 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A065013
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": "39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2",
"productndc": "39822-0412",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "065013",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1.2GM BASE/VIAL",
"product_no": "001",
"approval_date": "Aug 17, 2001"
}
],
"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": "g/30mL",
"application_number": "ANDA065013",
"marketing_category": "ANDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20010817",
"active_numerator_strength": "1.2"
}Related drugs
Other records sharing ATC code J01GB01.
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