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United States · US · US:24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b
Kitabis Pak
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPari Respiratory Equipment, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11244928505614 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
N205433
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": {
"da1e5afd-d707-4af1-8935-8195ba6d769f": {
"match": "brand_token",
"title": "KITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT, INC.]",
"spl_version": "10",
"published_date": "2024-12-13"
}
},
"productid": "24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b",
"productndc": "24492-850",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205433",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "Dec 2, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "Kitabis Pak",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA205433",
"marketing_category": "NDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20150219",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
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