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United States · US · US:0024-5862_fec4102e-2c66-433f-ab6c-7f420b4c3a86

Mozobil

In shortageOrange BookUNIISPLATC L03AX16

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

Identification

ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeL03AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
S915P5499N
PLERIXAFOR
RxCUI 733003
Orange Book
N022311
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Plerixafor Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "S915P5499N",
    "rxcui": "733003",
    "inchikey": "YIQPUIGJQJDJOS-UHFFFAOYSA-N",
    "display_name": "PLERIXAFOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "0ed08d2b-5051-46b2-aa37-1d6275bf9003": {
      "match": "brand_token",
      "title": "MOZOBIL (PLERIXAFOR) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "24",
      "published_date": "2025-09-25"
    }
  },
  "productid": "0024-5862_fec4102e-2c66-433f-ab6c-7f420b4c3a86",
  "productndc": "0024-5862",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022311",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "24MG/1.2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 15, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PLERIXAFOR",
  "shortage_reason": "Plerixafor Injection",
  "shortage_status": "current",
  "proprietary_name": "Mozobil",
  "active_ingred_unit": "mg/1.2mL",
  "application_number": "NDA022311",
  "marketing_category": "NDA",
  "nonproprietary_name": "PLERIXAFOR",
  "start_marketing_date": "20130901",
  "active_numerator_strength": "24"
}

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