Sterile Water

Orange BookUNIISPL

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

Identification

ManufacturerICU Medical Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0990711807
6 BAG in 1 CASE (0990-7118-07) / 2000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

N019869

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": "0990-7118_0b8830eb-7004-4d69-a2ea-07f39b56b69c",
  "productndc": "0990-7118",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019869",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100%",
        "product_no": "001",
        "approval_date": "Dec 26, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Sterile Water",
  "active_ingred_unit": "mL/mL",
  "application_number": "NDA019869",
  "marketing_category": "NDA",
  "nonproprietary_name": "WATER",
  "start_marketing_date": "20190601",
  "active_numerator_strength": "1"
}

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