🇺🇸
United States · US · US:10122-820_32442297-00c4-4800-b7c4-1e2e290f3162
BETHKIS
In shortageOrange BookUNIIATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChiesi USA, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1110122820044 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE
- ndc1110122820287 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
- ndc11101228205614 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
N201820
AN
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)",
"productid": "10122-820_32442297-00c4-4800-b7c4-1e2e290f3162",
"productndc": "10122-820",
"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": "BETHKIS",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA201820",
"marketing_category": "NDA",
"nonproprietary_name": "tobramycin",
"start_marketing_date": "20130415",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J01GB01.
- 🇨🇭Bramitob
- PLBramitobChiesi Farmaceutici S.p.A.
- NOBramitobChiesi Farmaceutici S.p.a.
- CZBRAMITOBChiesi Pharmaceuticals GmbH, Vídeň
- CZBRAMITOBChiesi Pharmaceuticals GmbH, Vídeň
- CZBRAMITOBChiesi Pharmaceuticals GmbH, Vídeň
- CZBRAMITOBChiesi Pharmaceuticals GmbH, Vídeň
- 🇪🇸BRAMITOB 300 mg/4 ml SOLUCION PARA INHALACION POR NEBULIZADORChiesi España S.A.U.
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