Sterile Water Injection, Solution
NDC Package 64253-020-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Sterile Water (sterile water for injection) injection is 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 formulation utilizes a injection, solution delivery system. Marketed by Medefil, Inc., this product is identified by NDC 64253-020 and is authorized under FDA application ANDA211188.

Identification & Billing

NDC Package Code
64253-020-91
Package Description
10 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC
Product Code
64253-020
11-Digit Billing Format
64253002091

Clinical Specifications

Proprietary Name
Sterile Water
Non-Proprietary Name
Sterile Water For Injection
Substance Name
Water
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
WATER 100 mL/100mL
Usage Information
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.

Regulatory & Marketing

Labeler Name
Medefil, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211188
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-27-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64253-020). Click a package code to view its specific billing and regulatory data.

64253-020-21
60 SYRINGE, PLASTIC in 1 BOX / 1 mL in 1 SYRINGE, PLASTIC
64253-020-23
60 SYRINGE, PLASTIC in 1 BOX / 3 mL in 1 SYRINGE, PLASTIC
64253-020-25
60 SYRINGE, PLASTIC in 1 BOX / 5 mL in 1 SYRINGE, PLASTIC
64253-020-30
60 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC
64253-020-35
60 SYRINGE, PLASTIC in 1 BOX / 5 mL in 1 SYRINGE, PLASTIC
64253-020-52
60 SYRINGE, PLASTIC in 1 BOX / 2.5 mL in 1 SYRINGE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64253-020-91 identifies a specific commercial package of 10 syringe, plastic in 1 box / 10 ml in 1 syringe, plastic of Sterile Water, a human prescription drug labeled by Medefil, Inc.. This injection, solution is formulated for intramuscular; intravenous; subcutaneous use and contains water as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Medefil, Inc. on January 27, 2020. The current certification is valid through December 31, 2026.

How is this Medefil, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64253002091. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
64253-020-91
11-Digit CMS (5-4-2)
64253-0020-91

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.