Sterile Diluent for Remodulin

Orange BookUNIISPL

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

Identification

ManufacturerUnited Therapeutics Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6630215050
1 VIAL in 1 BOX (66302-150-50) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

N021272

APAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "059QF0KO0R",
    "rxcui": "11295",
    "inchikey": "XLYOFNOQVPJJNP-UHFFFAOYSA-N",
    "display_name": "WATER",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "39df5fc7-f66e-1605-e063-6394a90a0054": {
      "match": "brand_token",
      "title": "STERILE ALCOHOL PAD PATCH [KINGSTAR MEDICAL (XIANNING) CO., LTD.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "66302-150_143d514e-fdcd-4766-ba47-0a75395e1f84",
  "productndc": "66302-150",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021272",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2.5MG/ML",
        "product_no": "002",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5MG/ML",
        "product_no": "003",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "004",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "005",
        "approval_date": "Jul 30, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/ML",
        "product_no": "006",
        "approval_date": "Sep 28, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/ML",
        "product_no": "007",
        "approval_date": "Sep 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/ML",
        "product_no": "008",
        "approval_date": "Sep 28, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Sterile Diluent for Remodulin",
  "active_ingred_unit": "mL/mL",
  "application_number": "NDA021272",
  "marketing_category": "NDA",
  "nonproprietary_name": "water",
  "start_marketing_date": "20141222",
  "active_numerator_strength": "1"
}

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