🇺🇸
United States · US · US:70842-240_2b7bcdc0-0333-42a1-942c-7b2efeb2398a
REZZAYO
Orange BookUNIISPLATC J02AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ02AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170842240011 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
G013B5478J
REZAFUNGIN
Orange Book
N217417
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G013B5478J",
"rxcui": null,
"inchikey": "LNFCWEXGZIEGJW-TXSVMFMRSA-O",
"display_name": "REZAFUNGIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"90073508-6dca-4d27-aa5a-ed837737c35b": {
"match": "brand_token",
"title": "REZZAYO (REZAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
"spl_version": "4",
"published_date": "2026-03-16"
}
},
"productid": "70842-240_2b7bcdc0-0333-42a1-942c-7b2efeb2398a",
"productndc": "70842-240",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217417",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE/VIAL",
"product_no": "001",
"approval_date": "Mar 22, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "REZAFUNGIN",
"proprietary_name": "REZZAYO",
"active_ingred_unit": "mg/1",
"application_number": "NDA217417",
"marketing_category": "NDA",
"nonproprietary_name": "rezafungin",
"start_marketing_date": "20230609",
"active_numerator_strength": "200"
}Related drugs
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- GBRezzayo 200mg powder for concentrate for solution for infusion vialsNapp Pharmaceuticals Ltd
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