Sterile Water (water) NDC 63323-185

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0185Add 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
63323-185-05	63323018505	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)Marketed from Apr 30, 2022
63323-185-10	63323018510	25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07)Marketed from Sep 5, 2000
63323-185-20	63323018520	25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)Marketed from Sep 5, 2000
63323-185-50	63323018550	25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)Marketed from Sep 5, 2000

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: Intramuscular, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088400
Marketing start: Sep 5, 2000
Listing expires: Dec 31, 2026
Identifiers: Product ID 63323-185_42c6c812-706a-425b-b8cb-931006e40484SPL ID 42c6c812-706a-425b-b8cb-931006e40484SPL set ID e71c6c83-d518-496c-b2ab-efd5987e4783UNII 059QF0KO0RUPC 0363323185084, 0363323185077, 0363323185046

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323018505 followed by a unit qualifier and the quantity

Package 63323-0185-05. 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

Current FDA label (SPL), effective Jun 9, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 088400

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

FDA NDC Directory listings under ANDA 088400
Product	Strength	Form · route	Labeler	Product NDC
Sterile Waterwater	Water 1 mL/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	65219-187
Sterile Waterwater	Water 1 mL/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Cardinal Health 107, LLC	55154-9588