Prescription drug · ANDA
Sterile Water (Water) NDC 55154-9588
Water 1 mL/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-9588-5 | 5515495880555154958805 | 5 VIAL in 1 BAG (55154-9588-5) / 10 mL in 1 VIALMarketed from Oct 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088400
- Marketing start
- Listing expires
- Identifiers
- Product ID 55154-9588_a50e5d40-a76a-48e5-8a40-0babe59acb69SPL ID a50e5d40-a76a-48e5-8a40-0babe59acb69SPL set ID 48d75a7c-8329-48a8-bea0-a8c144ddf637UNII 059QF0KO0RUPC 0055154958851
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
N455154958805followed by a unit qualifier and the quantityPackage 55154-9588-05. 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 .
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.
About NDC 55154-9588
- What is NDC 55154-9588?
- 55154-9588 is the product NDC for Sterile Water (water), Water 1 mL/mL injection, listed with the FDA by Cardinal Health 107, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 | InjectionIrrigation | Fresenius Kabi USA, LLC | 65219-499 | 65219-0499-30 |
| 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 088400
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 | InjectionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-185 |
| Sterile Waterwater | Water 1 mL/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 65219-187 |