{"boxed_warning":["NOT FOR DIRECT INJECTION"],"description":["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."],"effective_time":"20220131","how_supplied":["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"],"how_supplied_table":["<table><col width=\"33.333%\"/><col width=\"33.333%\"/><col width=\"33.333%\"/><tbody><tr><td valign=\"top\"> NDC 0517-3005-25 </td><td valign=\"top\"> 5 mL Single Dose Vial </td><td valign=\"top\"> Packaged in 25 </td></tr><tr><td valign=\"top\"> NDC 0517-3010-25 </td><td valign=\"top\"> 10 mL Single Dose Vial </td><td valign=\"top\"> Packaged in 25 </td></tr><tr><td valign=\"top\"> NDC 0517-3020-25 </td><td valign=\"top\"> 20 mL Single Dose Vial </td><td valign=\"top\"> Packaged in 25 </td></tr><tr><td valign=\"top\"> NDC 0517-3050-25 </td><td valign=\"top\"> 50 mL Single Dose Vial </td><td valign=\"top\"> Packaged in 25 </td></tr></tbody></table>"],"id":"b885fb92-786e-49bf-aed2-17b430e4743e","openfda":{"brand_name":["Sterile Water"],"generic_name":["WATER"],"is_original_packager":[true],"manufacturer_name":["American Regent, Inc."],"package_ndc":["0517-3005-01","0517-3005-25","0517-3010-01","0517-3010-25","0517-3020-01","0517-3020-25"],"product_ndc":["0517-3010","0517-3005","0517-3020"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["b885fb92-786e-49bf-aed2-17b430e4743e"],"spl_set_id":["78b35864-4bbc-4759-a5c1-7e4f25e22932"],"substance_name":["WATER"],"unii":["059QF0KO0R"],"upc":["0305173010253","0305173020252","0305173005259"]},"package_label_principal_display_panel":["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"],"precautions":["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."],"set_id":"78b35864-4bbc-4759-a5c1-7e4f25e22932","spl_product_data_elements":["Sterile Water Water WATER WATER Sterile Water Water WATER WATER Sterile Water Water WATER WATER"],"spl_unclassified_section":["Rx Only"],"version":"8"}