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United States · US · US:0990-7990_4deb57db-43cf-4a64-ae95-b217e3a4e5f1

Sterile Water

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

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
    0990799009
    12 POUCH in 1 CASE (0990-7990-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N018233
AP
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": "0990-7990_4deb57db-43cf-4a64-ae95-b217e3a4e5f1",
  "productndc": "0990-7990",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018233",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Sterile Water",
  "active_ingred_unit": "mL/1000mL",
  "application_number": "NDA018233",
  "marketing_category": "NDA",
  "nonproprietary_name": "water",
  "start_marketing_date": "20191001",
  "active_numerator_strength": "1000"
}

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