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United States · US · US:83296-100_26bdd232-8068-9080-e063-6394a90aa084

XOLREMDI

Orange BookUNIISPLATC L03AX24

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerX4 Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL03AX24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8329610012
    120 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-12)
  • ndc11
    8329610060
    60 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60)
  • ndc11
    8329610090
    90 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-90)

Annotations

UNII (FDA Substance ID)
0G9LGB5O2W
MAVORIXAFOR
Orange Book
N218709
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0G9LGB5O2W",
    "rxcui": null,
    "inchikey": "WVLHHLRVNDMIAR-IBGZPJMESA-N",
    "display_name": "MAVORIXAFOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7f3a5ee3-ca73-4876-85a0-ed1e108a2237": {
      "match": "brand_token",
      "title": "XOLREMDI (MAVORIXAFOR) CAPSULE, GELATIN COATED [X4 PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2024-11-18"
    }
  },
  "productid": "83296-100_26bdd232-8068-9080-e063-6394a90aa084",
  "productndc": "83296-100",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "218709",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAVORIXAFOR",
  "proprietary_name": "XOLREMDI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218709",
  "marketing_category": "NDA",
  "nonproprietary_name": "mavorixafor",
  "start_marketing_date": "20240521",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L03AX24.

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