Sterile Water

Orange BookUNIISPL

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

Identification

ManufacturerHenry Schein, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0404978110
1 VIAL in 1 BAG (0404-9781-10) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

A206369

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": "0404-9781_d2b21939-b988-410f-830c-e36a4b7f447f",
  "productndc": "0404-9781",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206369",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100% (10ML)",
        "product_no": "001",
        "approval_date": "Sep 2, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100% (20ML)",
        "product_no": "002",
        "approval_date": "Sep 2, 2015"
      }
    ],
    "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": "ANDA206369",
  "marketing_category": "ANDA",
  "nonproprietary_name": "water injection",
  "start_marketing_date": "20250828",
  "active_numerator_strength": "1"
}

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