sterile water

Generic: water

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sterile water
Generic Name water
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

water 1 mL/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-185
Product ID 63323-185_42c6c812-706a-425b-b8cb-931006e40484
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088400
Listing Expiration 2026-12-31
Marketing Start 2000-09-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323185
Hyphenated Format 63323-185

Supplemental Identifiers

UPC
0363323185084 0363323185077 0363323185046
UNII
059QF0KO0R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sterile water (source: ndc)
Generic Name water (source: ndc)
Application Number ANDA088400 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mL/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)
  • 25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07)
  • 25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)
  • 25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)
source: ndc

Packages (4)

63323-185-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) 63323-185-10 25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07) 63323-185-20 25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08) 63323-185-50 25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)

Ingredients (1)

water (1 mL/mL)

Linked Drug Pages (1)

Sterile Water ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "42c6c812-706a-425b-b8cb-931006e40484", "openfda": {"upc": ["0363323185084", "0363323185077", "0363323185046"], "unii": ["059QF0KO0R"], "spl_set_id": ["e71c6c83-d518-496c-b2ab-efd5987e4783"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)", "package_ndc": "63323-185-05", "marketing_start_date": "20220430"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-185-10)  / 10 mL in 1 VIAL (63323-185-07)", "package_ndc": "63323-185-10", "marketing_start_date": "20000905"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-185-20)  / 20 mL in 1 VIAL (63323-185-08)", "package_ndc": "63323-185-20", "marketing_start_date": "20000905"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-185-50)  / 50 mL in 1 VIAL (63323-185-09)", "package_ndc": "63323-185-50", "marketing_start_date": "20000905"}], "brand_name": "Sterile Water", "product_id": "63323-185_42c6c812-706a-425b-b8cb-931006e40484", "dosage_form": "INJECTION", "product_ndc": "63323-185", "generic_name": "WATER", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sterile Water", "active_ingredients": [{"name": "WATER", "strength": "1 mL/mL"}], "application_number": "ANDA088400", "marketing_category": "ANDA", "marketing_start_date": "20000905", "listing_expiration_date": "20261231"}