Back to search
🇺🇸

United States · US · US:64067-216_ae164681-3533-4dde-adc2-7b35af9c4f6d

UVADEX

Orange BookUNIISPLATC D05BA02

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

Identification

ManufacturerTherakos LLC
CountryUS (United States)
ATC codeD05BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6406721601
    12 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
U4VJ29L7BQ
METHOXSALEN
RxCUI 6854
Orange Book
N020969
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U4VJ29L7BQ",
    "rxcui": "6854",
    "inchikey": "QXKHYNVANLEOEG-UHFFFAOYSA-N",
    "display_name": "METHOXSALEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EXTRACORPOREAL",
  "spl_meta": {
    "5ad333bd-845f-43f8-9ecf-43491f26c7c7": {
      "match": "brand_token",
      "title": "UVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS LLC]",
      "spl_version": "17",
      "published_date": "2024-12-20"
    }
  },
  "productid": "64067-216_ae164681-3533-4dde-adc2-7b35af9c4f6d",
  "productndc": "64067-216",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020969",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG/ML",
        "product_no": "001",
        "approval_date": "Feb 25, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOXSALEN",
  "proprietary_name": "UVADEX",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA020969",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methoxsalen",
  "start_marketing_date": "19990225",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code D05BA02.

Access this data programmatically

Query UVADEX and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.