Sterile Water
Water
American Regent, Inc.
Human Prescription Drug
NDC 0517-3010Sterile Water also known as Water is a human prescription drug labeled by 'American Regent, Inc.'. National Drug Code (NDC) number for Sterile Water is 0517-3010. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sterile Water drug includes Water - 1 mL/mL . The currest status of Sterile Water drug is Active.
Drug Information:
| Drug NDC: | 0517-3010 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sterile Water |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Regent, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | WATER - 1 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | American Regent, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0305173010253
0305173020252
0305173005259
|
| UPC stands for Universal Product Code. |
| UNII: | 059QF0KO0R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0517-3010-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-3010-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-3010-01) | 22 Apr, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sterile water water water water sterile water water water water sterile water water water water
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.
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
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