Sterile Water

Orange BookUNIISPL

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

Identification

ManufacturerMedefil, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6425302021
60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC
ndc11
6425302023
60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC
ndc11
6425302025
60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTIC
ndc11
6425302030
60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTIC
ndc11
6425302035
60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTIC
ndc11
6425302052
60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC
ndc11
6425302091
10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

A211188

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": "64253-020_2b39b41d-419a-dab8-e063-6394a90a319a",
  "productndc": "64253-020",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100% (1ML)",
        "product_no": "001",
        "approval_date": "Dec 2, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100% (2.5ML)",
        "product_no": "002",
        "approval_date": "Dec 2, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100% (3ML)",
        "product_no": "003",
        "approval_date": "Dec 2, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "100% (5ML)",
        "product_no": "004",
        "approval_date": "Dec 2, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100% (10ML)",
        "product_no": "005",
        "approval_date": "Dec 2, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Sterile Water",
  "active_ingred_unit": "mL/100mL",
  "application_number": "ANDA211188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sterile Water for Injection",
  "start_marketing_date": "20200127",
  "active_numerator_strength": "100"
}

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