Sterile Water (water) NDC 65219-497

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0497Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-497-20	65219049720	5 BAG in 1 CASE (65219-497-20) / 2000 mL in 1 BAG (65219-497-02)Marketed from Dec 19, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Sterile Water
Generic name (nonproprietary): water
Active ingredients: Water — 1 mL/mL
Dosage form: Injection
Route: Irrigation
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216123
Marketing start: Dec 19, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 65219-497_7cd9f528-a5da-4541-bb2a-28f3669a6b42SPL ID 7cd9f528-a5da-4541-bb2a-28f3669a6b42SPL set ID fd823bef-c14c-4708-a18a-8aaa8470412fRxCUI 150985UNII 059QF0KO0R

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465219049720 followed by a unit qualifier and the quantity

Package 65219-0497-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 216123

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216123
Product	Strength	Form · route	Labeler	Product NDC
Sterile Waterwater	Water 1 mL/mL	InjectionIrrigation	Becton Dickinson and Company	17271-802
Sterile Waterwater	Water 1 mL/mL	InjectionIrrigation	Fresenius Kabi USA, LLC	65219-495
Sterile Waterwater	Water 1 mL/mL	InjectionIrrigation	Fresenius Kabi USA, LLC	65219-499