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United States · US · US:49502-401_0ebb786f-98a7-47b4-a0ef-06c0412ca3da
TOBI Podhaler
In shortageOrange BookUNIISPLATC J01GB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeJ01GB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1149502401098 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)
- ndc114950240124224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK
- ndc1149502401577 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
N201688
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": "ORAL; RESPIRATORY (INHALATION)",
"spl_meta": {
"c4b5bb1f-e158-4ac1-9c35-e98a416c743a": {
"match": "brand_token",
"title": "TOBI PODHALER (TOBRAMYCIN) CAPSULE [VIATRIS SPECIALTY LLC]",
"spl_version": "12",
"published_date": "2025-11-17"
}
},
"productid": "49502-401_0ebb786f-98a7-47b4-a0ef-06c0412ca3da",
"productndc": "49502-401",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "201688",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "28MG",
"product_no": "001",
"approval_date": "Mar 22, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOBRAMYCIN",
"shortage_reason": "Tobramycin Solution",
"shortage_status": "current",
"proprietary_name": "TOBI Podhaler",
"active_ingred_unit": "mg/1",
"application_number": "NDA201688",
"marketing_category": "NDA",
"nonproprietary_name": "Tobramycin",
"start_marketing_date": "20210901",
"active_numerator_strength": "28"
}Related drugs
Other records sharing ATC code J01GB01.
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