Prescription drug · NDA
Sterile Water (Water) NDC 0338-0004
Water 100 mL/100mL · Irrigant · Irrigation · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0004-02 | 00338000402 | 24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 | |
| 0338-0004-03 | 00338000403 | 18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 | |
| 0338-0004-04 | 00338000404 | 12 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 |
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 — 100 mL/100mL
- Dosage form
- Irrigant
- Route
- Irrigation
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017428
- Marketing start
- Listing expires
- Identifiers
- Product ID 0338-0004_97390588-b679-4caa-b7f3-3d2e11074d0eSPL ID 97390588-b679-4caa-b7f3-3d2e11074d0eSPL set ID ef3e79c5-3f58-4b36-a296-64b7d9a651c1RxCUI 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
N400338000402followed by a unit qualifier and the quantityPackage 00338-0004-02. 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)
Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0338-0004
- What is NDC 0338-0004?
- 0338-0004 is the product NDC for Sterile Water (water), Water 100 mL/100mL irrigant, listed with the FDA by Baxter Healthcare Corporation. It has 3 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?
- Baxter Healthcare Corporation, NDC labeler code 0338. 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 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 |