Phospholine Iodide

Orange BookSPL

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

Identification

ManufacturerFera Pharmaceuticals, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4810205305
1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05)

Annotations

Orange Book

N011963

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "OPHTHALMIC",
  "spl_meta": {
    "8afc8951-db76-4f27-8752-7c0d6aa47244": {
      "match": "brand_token",
      "title": "PHOSPHOLINE IODIDE (ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION) KIT [FERA PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2025-07-08"
    }
  },
  "productid": "48102-053_66abcfcf-b16e-4181-b1db-96bfba0ab95e",
  "productndc": "48102-053",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "011963",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.125%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.03%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.25%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.06%",
        "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": "Phospholine Iodide",
  "active_ingred_unit": null,
  "application_number": "NDA011963",
  "marketing_category": "NDA",
  "nonproprietary_name": "echothiophate iodide for ophthalmic solution",
  "start_marketing_date": "20220601",
  "active_numerator_strength": null
}

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