Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 0517-3020 | ||||
|---|---|---|---|---|---|
| Drug Name | Sterile water |
||||
| Type | Brand | ||||
| Active Ingredients |
|
||||
| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| Labeler Name | American Regent, Inc. | ||||
| Packages |
|
||||
| Check if available Online | Get Medication Prices online with Discount |
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.
Spl product data elements
Usually a list of ingredients in a drug product.Sterile Water Water WATER WATER Sterile Water Water WATER WATER Sterile Water Water WATER WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 5 mL Contain NDC 0517-3005-01 STERILE WATER FOR INJECTION, USP 5 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3005-25 25 x 5 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 5 mL container label Carton
PRINCIPAL DISPLAY PANEL - 10 mL Container NDC 0517-3010-01 STERILE WATER FOR INJECTION, USP 10 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3010-25 25 x 10 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 10 mL container label Carton Labeling - 10 mL
PRINCIPAL DISPLAY PANEL - 20 mL Container NDC 0517-3020-01 STERILE WATER FOR INJECTION, USP 20 mL SINGLE DOSE VIAL FOR DRUG DILUENT USE Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton STERILE WATER FOR INJECTION, USP NDC 0517-3020-25 25 x 20 mL SINGLE DOSE VIALS FOR DRUG DILUENT USE Rx Only No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 5/18 20 mL container label Carton Labeling - 20 mL
Serialization Label - 5 mL Serialization Label - 5 mL
Serialization Label - 10 mL Serialization Label - 10 mL
Serialization Label - 20 mL Serialization Label - 20 mL
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED: Sterile Water for Injection, USP NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25 NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25 NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25 NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN3005 Rev. 1/09
| NDC 0517-3005-25 | 5 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3010-25 | 10 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3020-25 | 20 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3050-25 | 50 mL Single Dose Vial | Packaged in 25 |
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.NOT FOR DIRECT INJECTION
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API