IC-Green

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRenew Pharmaceuticals Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7010082502
6 PACKAGE in 1 CARTON (70100-825-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-725-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

Annotations

Orange Book

N011525

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "ccd92843-1f0a-4ece-9978-4b300d158886": {
      "match": "brand_token",
      "title": "IC-GREEN (INDOCYANINE GREEN) KIT [RENEW PHARMACEUTICALS LIMITED]",
      "spl_version": "4",
      "published_date": "2026-04-15"
    }
  },
  "productid": "70100-825_bb82db71-b087-4274-bd9c-cb388d7dbaeb",
  "productndc": "70100-825",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "011525",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "IC-Green",
  "active_ingred_unit": null,
  "application_number": "NDA011525",
  "marketing_category": "NDA",
  "nonproprietary_name": "Indocyanine Green",
  "start_marketing_date": "20250415",
  "active_numerator_strength": null
}

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