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United States · US · US:66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c
Tobramycin Inhalation
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco, LLC
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11669931959414 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
N201820
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": "66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c",
"productndc": "66993-195",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "201820",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "300MG/4ML",
"product_no": "001",
"approval_date": "Oct 12, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "Tobramycin Inhalation",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA201820",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "tobramycin inhalation",
"start_marketing_date": "20200915",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
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