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, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

water 1000 mL/1000mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-178
Product ID 63323-178_d40f0ff2-4abf-4030-b4e1-2b85ad7448a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209689
Listing Expiration 2026-12-31
Marketing Start 2017-11-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323178
Hyphenated Format 63323-178

Supplemental Identifiers

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 ANDA209689 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 mL/1000mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG
source: ndc

Packages (1)

63323-178-76 10 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG

Ingredients (1)

water (1000 mL/1000mL)

Linked Drug Pages (1)

Sterile Water ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d40f0ff2-4abf-4030-b4e1-2b85ad7448a0", "openfda": {"unii": ["059QF0KO0R"], "spl_set_id": ["b45e9f1d-9c48-4b46-8541-d846b89540df"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (63323-178-76)  / 1000 mL in 1 BAG", "package_ndc": "63323-178-76", "marketing_start_date": "20171124"}], "brand_name": "Sterile Water", "product_id": "63323-178_d40f0ff2-4abf-4030-b4e1-2b85ad7448a0", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-178", "generic_name": "Water", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sterile Water", "active_ingredients": [{"name": "WATER", "strength": "1000 mL/1000mL"}], "application_number": "ANDA209689", "marketing_category": "ANDA", "marketing_start_date": "20171124", "listing_expiration_date": "20261231"}