Prescription drug · ANDA
Sterile Water (Water) NDC 65219-499
Water 1 mL/mL · Injection · Irrigation · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-499-30 | 6521904993065219049930 | 4 BAG in 1 CASE (65219-499-30) / 3000 mL in 1 BAG (65219-499-03)Marketed from Mar 3, 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, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216123
- Marketing start
- Listing expires
- Identifiers
- Product ID 65219-499_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
N465219049930followed by a unit qualifier and the quantityPackage 65219-0499-30. 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 Irrigation is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).
Excerpt only. Read the full label for complete information.
About NDC 65219-499
- What is NDC 65219-499?
- 65219-499 is the product NDC for Sterile Water (water), Water 1 mL/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sterile Water (Water).
- What is the active ingredient?
- Water.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sterile Water?
- 42 other product NDCs are listed under this name. See all Sterile Water NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sterile Water products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sterile Waterwater | Water 1 mL/mL | InjectionIntramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4732 | 70518-4732-01 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIrrigation | Fresenius Kabi USA, LLC | 65219-495 | 65219-0495-10 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIrrigation | Fresenius Kabi USA, LLC | 65219-497 | 65219-0497-20 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIrrigation | Becton Dickinson and Company | 17271-802 | 17271-0802-0717271-0802-0817271-0802-09 |
| Sterile Waterwater injection | Water 1 mL/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | 0404-9781 | 00404-9781-10 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-0024 | 00409-0024-10 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-9588 | 55154-9588-05 |
| Sterile Water | Water 1 mL/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9339 | 00143-9339-12 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 65219-187 | 65219-0187-10 |
| Sterile Waterwater | Water 1 mL/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-3010 | 00517-3010-25 |
Other NDCs under ANDA 216123
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 | 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 | 65219-497 |