Indocyanine 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
7010042402
6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

Annotations

Orange Book

A040811

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "a6f24787-c243-445a-9c55-7c7479b292d9": {
      "match": "brand_token",
      "title": "INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [RENEW PHARMACEUTICALS LIMITED]",
      "spl_version": "9",
      "published_date": "2025-04-23"
    }
  },
  "productid": "70100-424_3abdfd10-c4e6-472e-b4eb-d4953f029132",
  "productndc": "70100-424",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "040811",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/VIAL",
        "product_no": "001",
        "approval_date": "Nov 21, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Indocyanine Green",
  "active_ingred_unit": null,
  "application_number": "ANDA040811",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indocyanine Green and Water",
  "start_marketing_date": "20080101",
  "active_numerator_strength": null
}

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