Sterile Water

Orange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6332318505
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)
ndc11
6332318510
25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07)
ndc11
6332318520
25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)
ndc11
6332318550
25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

A088400

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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "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": "63323-185_42c6c812-706a-425b-b8cb-931006e40484",
  "productndc": "63323-185",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "088400",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100%",
        "product_no": "001",
        "approval_date": "Jan 16, 1984"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Sterile Water",
  "active_ingred_unit": "mL/mL",
  "application_number": "ANDA088400",
  "marketing_category": "ANDA",
  "nonproprietary_name": "WATER",
  "start_marketing_date": "20000905",
  "active_numerator_strength": "1"
}

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