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United States · US · US:0093-3750_8aa98982-a156-4bc8-8d31-9a39b88808ed
Tobramycin
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100933750287 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
- ndc11009337506314 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A210915
AN
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": "RESPIRATORY (INHALATION)",
"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": "0093-3750_8aa98982-a156-4bc8-8d31-9a39b88808ed",
"productndc": "0093-3750",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "210915",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "300MG/4ML",
"product_no": "001",
"approval_date": "Jun 26, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "Tobramycin",
"active_ingred_unit": "mg/4mL",
"application_number": "ANDA210915",
"marketing_category": "ANDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20200915",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
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