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United States · US · US:76128-155_a11b84ff-6eb6-4bba-9c7c-6d41bdfe2d57

Photofrin

Orange BookUNIISPLATC L01XD01

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

Identification

ManufacturerPinnacle Biologics, Inc.
CountryUS (United States)
ATC codeL01XD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7612815575
    1 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
Y3834SIK5F
PORFIMER SODIUM
RxCUI 333848
Orange Book
N020451
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Y3834SIK5F",
    "rxcui": "333848",
    "inchikey": null,
    "display_name": "PORFIMER SODIUM",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5c4841b4-fbc0-4163-8ee1-cb28629cbfbf": {
      "match": "brand_token",
      "title": "PHOTOFRIN (PORFIMER SODIUM) INJECTION, POWDER, FOR SOLUTION [PINNACLE BIOLOGICS, INC.]",
      "spl_version": "15",
      "published_date": "2026-04-30"
    }
  },
  "productid": "76128-155_a11b84ff-6eb6-4bba-9c7c-6d41bdfe2d57",
  "productndc": "76128-155",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020451",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 27, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PORFIMER SODIUM",
  "proprietary_name": "Photofrin",
  "active_ingred_unit": "mg/31.8mL",
  "application_number": "NDA020451",
  "marketing_category": "NDA",
  "nonproprietary_name": "Porfimer Sodium",
  "start_marketing_date": "19951227",
  "active_numerator_strength": "75"
}

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