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 65219-187
Product ID 65219-187_0a672bdf-163d-4af5-a791-f815de5b309c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088400
Listing Expiration 2026-12-31
Marketing Start 2022-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219187
Hyphenated Format 65219-187

Supplemental Identifiers

UPC
0365219187011
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 (65219-187-10) / 100 mL in 1 VIAL, SINGLE-DOSE (65219-187-01)
source: ndc

Packages (1)

65219-187-10 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-187-10) / 100 mL in 1 VIAL, SINGLE-DOSE (65219-187-01)

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": "0a672bdf-163d-4af5-a791-f815de5b309c", "openfda": {"upc": ["0365219187011"], "unii": ["059QF0KO0R"], "spl_set_id": ["f42ac50f-0ec5-4713-a4c8-99d972d90bed"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-187-10)  / 100 mL in 1 VIAL, SINGLE-DOSE (65219-187-01)", "package_ndc": "65219-187-10", "marketing_start_date": "20220429"}], "brand_name": "Sterile Water", "product_id": "65219-187_0a672bdf-163d-4af5-a791-f815de5b309c", "dosage_form": "INJECTION", "product_ndc": "65219-187", "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": "20220429", "listing_expiration_date": "20261231"}