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United States · US · US:68083-321_9f57066e-9301-4770-87df-29a62a42decc
Voriconazole
In shortageOrange BookUNIISPLATC J02AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeJ02AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083321011 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
JFU09I87TR
VORICONAZOLE
RxCUI 121243
Orange Book
A211099
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Voriconazole Tablet
Raw payload (JSON)
{
"unii": {
"unii": "JFU09I87TR",
"rxcui": "121243",
"inchikey": "BCEHBSKCWLPMDN-MGPLVRAMSA-N",
"display_name": "VORICONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"23f25c6b-f075-42dc-ae05-63b5bf410929": {
"match": "brand_token",
"title": "VORICONAZOLE TABLET, FILM COATED [SAFECOR HEALTH LLC]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "68083-321_9f57066e-9301-4770-87df-29a62a42decc",
"productndc": "68083-321",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "211099",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/VIAL",
"product_no": "001",
"approval_date": "Mar 31, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VORICONAZOLE",
"shortage_reason": "Voriconazole Tablet",
"shortage_status": "current",
"proprietary_name": "Voriconazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211099",
"marketing_category": "ANDA",
"nonproprietary_name": "Voriconazole",
"start_marketing_date": "20200331",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J02AC03.
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