Sterile Water

Orange BookUNIISPL

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009028741
25 VIAL, PLASTIC in 1 TRAY (50090-2874-1) / 10 mL in 1 VIAL, PLASTIC

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": "50090-2874_e2b83474-2d42-41ae-96e6-94c838fde0a0",
  "productndc": "50090-2874",
  "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        "strength": "100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "20050616",
  "active_numerator_strength": "1"
}

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