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United States · US · US:43598-308_1df6ec0d-0508-29af-33c2-3a9d19a040df

Plerixafor

In shortageOrange BookUNIISPLATC L03AX16

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

Identification

ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeL03AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359830823
    1 VIAL, SINGLE-DOSE in 1 CARTON (43598-308-23) / 1.2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
S915P5499N
PLERIXAFOR
RxCUI 733003
Orange Book
A205182
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": "43598-308_1df6ec0d-0508-29af-33c2-3a9d19a040df",
  "productndc": "43598-308",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "205182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "24MG/1.2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 24, 2023"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA205182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Plerixafor",
  "start_marketing_date": "20231106",
  "active_numerator_strength": "24"
}

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