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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

  • ndc11
    6854791510
    1 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"
}

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