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United States · US · US:72893-005_08d15e08-706e-4f2c-af12-bee22e1b8251

Folotyn

Orange BookUNIISPLATC L01BA05

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

Identification

ManufacturerAcrotech Biopharma Inc
CountryUS (United States)
ATC codeL01BA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7289300501
    1 VIAL in 1 CARTON (72893-005-01) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
A8Q8I19Q20
PRALATREXATE
RxCUI 662019
Orange Book
N022468
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A8Q8I19Q20",
    "rxcui": "662019",
    "inchikey": "OGSBUKJUDHAQEA-WMCAAGNKSA-N",
    "display_name": "PRALATREXATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9f3d9c4d-9386-4451-b712-0fbdc5478d8f": {
      "match": "brand_token",
      "title": "FOLOTYN (PRALATREXATE) INJECTION [ACROTECH BIOPHARMA INC]",
      "spl_version": "9",
      "published_date": "2024-09-27"
    }
  },
  "productid": "72893-005_08d15e08-706e-4f2c-af12-bee22e1b8251",
  "productndc": "72893-005",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022468",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 24, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/2ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 24, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRALATREXATE",
  "proprietary_name": "Folotyn",
  "active_ingred_unit": "mg/2mL",
  "application_number": "NDA022468",
  "marketing_category": "NDA",
  "nonproprietary_name": "pralatrexate",
  "start_marketing_date": "20090924",
  "active_numerator_strength": "40"
}

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