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United States · US · US:65219-284_ba468eca-fb47-497b-8aed-a1576249ea6a

Plerixafor

In shortageOrange BookUNIISPLATC L03AX16

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

Identification

ManufacturerFresenius Kabi Usa, LLC
CountryUS (United States)
ATC codeL03AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521928412
    1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE

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": {
    "b42fda2a-80c8-4bdd-a91d-03d11bef064a": {
      "match": "brand_token",
      "title": "PLERIXAFOR INJECTION, SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-05-11"
    }
  },
  "productid": "65219-284_ba468eca-fb47-497b-8aed-a1576249ea6a",
  "productndc": "65219-284",
  "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": "Plerixafor",
  "active_ingred_unit": "mg/1.2mL",
  "application_number": "NDA022311",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "PLERIXAFOR",
  "start_marketing_date": "20230622",
  "active_numerator_strength": "24"
}

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