Bacteriostatic Water

Orange BookUNIISPL

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

Identification

ManufacturerProPharma Distribution

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8454997703
30 mL in 1 VIAL, MULTI-DOSE (84549-977-03)

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

N018802

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": {
    "376093e7-e09e-4a57-3199-195e45251866": {
      "match": "brand_token",
      "title": "BACTERIOSTATIC SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "23",
      "published_date": "2026-04-06"
    }
  },
  "productid": "84549-977_42c6938e-f748-ae13-e063-6294a90a59a3",
  "productndc": "84549-977",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018802",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100%",
        "product_no": "001",
        "approval_date": "Oct 27, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WATER",
  "proprietary_name": "Bacteriostatic Water",
  "active_ingred_unit": "mL/mL",
  "application_number": "NDA018802",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bacteriostatic Water",
  "start_marketing_date": "20050430",
  "active_numerator_strength": "1"
}

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