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
IRRIGATION
Active Ingredients

water 1 mL/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-497
Product ID 65219-497_7cd9f528-a5da-4541-bb2a-28f3669a6b42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216123
Listing Expiration 2026-12-31
Marketing Start 2025-12-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219497
Hyphenated Format 65219-497

Supplemental Identifiers

RxCUI
150985
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 ANDA216123 (source: ndc)
Routes
IRRIGATION
source: ndc

Resolved Composition

Strengths
  • 1 mL/mL
source: ndc
Packaging
  • 5 BAG in 1 CASE (65219-497-20) / 2000 mL in 1 BAG (65219-497-02)
source: ndc

Packages (1)

65219-497-20 5 BAG in 1 CASE (65219-497-20) / 2000 mL in 1 BAG (65219-497-02)

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": ["IRRIGATION"], "spl_id": "7cd9f528-a5da-4541-bb2a-28f3669a6b42", "openfda": {"unii": ["059QF0KO0R"], "rxcui": ["150985"], "spl_set_id": ["fd823bef-c14c-4708-a18a-8aaa8470412f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BAG in 1 CASE (65219-497-20)  / 2000 mL in 1 BAG (65219-497-02)", "package_ndc": "65219-497-20", "marketing_start_date": "20251219"}], "brand_name": "Sterile Water", "product_id": "65219-497_7cd9f528-a5da-4541-bb2a-28f3669a6b42", "dosage_form": "INJECTION", "product_ndc": "65219-497", "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": "ANDA216123", "marketing_category": "ANDA", "marketing_start_date": "20251219", "listing_expiration_date": "20261231"}