Prescription drug · NDA
Sterile Water (water) NDC 84549-850
Water 1 mL/mL · Injection · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-850-10 | 84549085010 | 500 mL in 1 CONTAINER (84549-850-10)Marketed from Sep 18, 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
- Intravenous
- Labeler
- ProPharma Distribution
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019633
- Marketing start
- Listing expires
- Identifiers
- Product ID 84549-850_3f2ae8c1-304e-b61a-e063-6394a90a41ccSPL ID 3f2ae8c1-304e-b61a-e063-6394a90a41ccSPL set ID 3f2ae880-852f-b45d-e063-6394a90aa1ccUNII 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.
- 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.
- NDC on a medical claim
N484549085010followed by a unit qualifier and the quantityPackage 84549-0850-10. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019633
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sterile Waterwater | Water 1 mL/mL | InjectionIntravenous | B. Braun Medical Inc. | 0264-7850 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIntravenous | B. Braun Medical Inc. | 0264-7385 |