Prescription drug · NDA
Sterile Water (Water) NDC 0264-7385
Water 1 mL/mL · Injection · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-7385-50 | 0026473855000264738550 | 4 CONTAINER in 1 CASE (0264-7385-50) / 2000 mL in 1 CONTAINERMarketed from Sep 4, 2014 | |
| 0264-7385-60 | 0026473856000264738560 | 4 CONTAINER in 1 CASE (0264-7385-60) / 3000 mL in 1 CONTAINERMarketed from Sep 4, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019633
- Marketing start
- Listing expires
- Identifiers
- Product ID 0264-7385_ed933e44-2560-495b-879c-99c6a0bf8ba0SPL ID ed933e44-2560-495b-879c-99c6a0bf8ba0SPL set ID 8924e52e-8622-4ed6-a061-1908183e0a18UNII 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
N400264738550followed by a unit qualifier and the quantityPackage 00264-7385-50. 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 in the aseptic preparation of parenteral solutions or as a vehicle for drug administration after admixture or dilution.
Excerpt only. Read the full label for complete information.
About NDC 0264-7385
- What is NDC 0264-7385?
- 0264-7385 is the product NDC for Sterile Water (water), Water 1 mL/mL injection, listed with the FDA by B. Braun Medical Inc.. It has 2 package NDCs, 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?
- B. Braun Medical Inc., NDC labeler code 0264. 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?
- 43 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 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 |
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 | ProPharma Distribution | 84549-850 |