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 · 3

ndc11
0404995910
1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-10) / 10 mL in 1 VIAL, SINGLE-DOSE
ndc11
0404995920
1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-20) / 20 mL in 1 VIAL, SINGLE-DOSE
ndc11
0404995950
1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

N018801

APAP

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": "0404-9959_2d56a116-dc8f-4835-b3f4-78128cb907aa",
  "productndc": "0404-9959",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018801",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Oct 27, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100% (10ML)",
        "product_no": "002",
        "approval_date": "Oct 27, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100% (20ML)",
        "product_no": "003",
        "approval_date": "Oct 27, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100% (50ML)",
        "product_no": "004",
        "approval_date": "Oct 27, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100% (100ML)",
        "product_no": "005",
        "approval_date": "Oct 27, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "May 2, 2023"
      }
    ],
    "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": "NDA018801",
  "marketing_category": "NDA",
  "nonproprietary_name": "Water",
  "start_marketing_date": "20220112",
  "active_numerator_strength": "1"
}

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