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United States · US · US:82737-073_241b0b4f-eca3-be93-e063-6394a90a5789

Aphexda

Orange BookUNIISPLATC L03AX23

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

Identification

ManufacturerBioLineRx USA Inc
CountryUS (United States)
ATC codeL03AX23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8273707301
    1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
3ZPX60DV8A
MOTIXAFORTIDE ACETATE
Orange Book
N217159
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3ZPX60DV8A",
    "rxcui": null,
    "inchikey": "GMUZYOKQKWMETH-MEMSBXIYSA-N",
    "display_name": "MOTIXAFORTIDE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "e704b2db-f119-40ba-9346-9229e3281c9e": {
      "match": "brand_token",
      "title": "APHEXDA (MOTIXAFORTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GAMIDA CELL INC.]",
      "spl_version": "4",
      "published_date": "2026-02-06"
    }
  },
  "productid": "82737-073_241b0b4f-eca3-be93-e063-6394a90a5789",
  "productndc": "82737-073",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "217159",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 62MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 8, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOTIXAFORTIDE ACETATE",
  "proprietary_name": "Aphexda",
  "active_ingred_unit": "mg/1.7mL",
  "application_number": "NDA217159",
  "marketing_category": "NDA",
  "nonproprietary_name": "Motixafortide",
  "start_marketing_date": "20230908",
  "active_numerator_strength": "62"
}

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