Prescription drug · ANDA
Sterile Water (Sterile water for injection) NDC 64253-020
Water 100 mL/100mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Medefil, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64253-020-21 | 6425300202164253002021 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTICMarketed from Jan 27, 2020 | |
| 64253-020-23 | 6425300202364253002023 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTICMarketed from Jan 27, 2020 | |
| 64253-020-25 | 6425300202564253002025 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTICMarketed from Sep 21, 2020 | |
| 64253-020-30 | 6425300203064253002030 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTICMarketed from Jan 27, 2020 | |
| 64253-020-35 | 6425300203564253002035 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTICMarketed from Jan 27, 2020 | |
| 64253-020-52 | 6425300205264253002052 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTICMarketed from Jan 27, 2020 | |
| 64253-020-91 | 6425300209164253002091 | 10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTICMarketed from Sep 21, 2020 |
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)
- sterile water for injection
- Active ingredients
- Water — 100 mL/100mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Medefil, Inc.NDC labeler code 64253
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211188
- Marketing start
- Listing expires
- Identifiers
- Product ID 64253-020_2b39b41d-419a-dab8-e063-6394a90a319aSPL ID 2b39b41d-419a-dab8-e063-6394a90a319aSPL set ID 99e99a50-82d5-aff6-e053-2a95a90a8c56UNII 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
N464253002021followed by a unit qualifier and the quantityPackage 64253-0020-21. 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)
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. 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 64253-020
- What is NDC 64253-020?
- 64253-020 is the product NDC for Sterile Water (sterile water for injection), Water 100 mL/100mL injection, solution, listed with the FDA by Medefil, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sterile Water (Sterile Water for Injection).
- What is the active ingredient?
- Water.
- Who is the labeler?
- Medefil, Inc., NDC labeler code 64253. 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 |