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United States · US · US:47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3
Tobramycin
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11473351714914 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A207136
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": "47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3",
"productndc": "47335-171",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207136",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "Dec 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/5mL",
"application_number": "ANDA207136",
"marketing_category": "ANDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20200228",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
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