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United States · US · US:43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede
Tobramycin Inhalation Solution
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435986055614 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE
- ndc11435986055856 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A207080
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": "43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede",
"productndc": "43598-605",
"dosage_form": "INHALANT",
"orange_book": {
"appl_no": "207080",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "Jul 9, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "Tobramycin Inhalation Solution",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA207080",
"marketing_category": "ANDA",
"nonproprietary_name": "Tobramycin Inhalation Solution",
"start_marketing_date": "20190514",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
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