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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
- ndc118329610012120 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-12)
- ndc11832961006060 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60)
- ndc11832961009090 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.
- FIXolremdiX4 Pharmaceuticals (Austria) GmbH
- CZXOLREMDIX4 Pharmaceuticals (Austria) GmbH, Vídeň
- CZXOLREMDIX4 Pharmaceuticals (Austria) GmbH, Vídeň
- CZXOLREMDIX4 Pharmaceuticals (Austria) GmbH, Vídeň
- BEXolremdi 100 mgX4 Pharmaceuticals (Austria)
- NLXolremdi 100 mg harde capsuleX4 Pharmaceuticals (Austria) GmbH
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