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United States · US · US:68547-915_1835ee35-6c63-46c0-856f-6205e76af7b9
NUZOLVENCE
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLa Jolla Pharmaceutical Company
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168547915101 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET
Annotations
UNII (FDA Substance ID)
FWL2263R77
ZOLIFLODACIN
Orange Book
N219491
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FWL2263R77",
"rxcui": null,
"inchikey": "ZSWMIFNWDQEXDT-ZESJGQACSA-N",
"display_name": "ZOLIFLODACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4beda35a-21b0-4b34-84ea-be6ea8cae50f": {
"match": "brand_token",
"title": "NUZOLVENCE (ZOLIFLODACIN) FOR SUSPENSION [LA JOLLA PHARMACEUTICAL COMPANY]",
"spl_version": "3",
"published_date": "2026-04-02"
}
},
"productid": "68547-915_1835ee35-6c63-46c0-856f-6205e76af7b9",
"productndc": "68547-915",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "219491",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3GM/PACKET",
"product_no": "001",
"approval_date": "Dec 12, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLIFLODACIN",
"proprietary_name": "NUZOLVENCE",
"active_ingred_unit": "g/1",
"application_number": "NDA219491",
"marketing_category": "NDA",
"nonproprietary_name": "zoliflodacin",
"start_marketing_date": "20260401",
"active_numerator_strength": "3"
}Access this data programmatically
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