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United States · US · US:0409-3977_e421caa9-6011-4cdf-a16c-6fe96d8b958a

Bacteriostatic Water

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409397703
    25 VIAL, MULTI-DOSE in 1 TRAY (0409-3977-03) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3977-01)

Annotations

UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N018802
AP
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": "0409-3977_e421caa9-6011-4cdf-a16c-6fe96d8b958a",
  "productndc": "0409-3977",
  "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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