Sterile Water
Nephron Pharmaceuticals Corporation
Human Prescription Drug
NDC 0487-6105Sterile Water is a human prescription drug labeled by 'Nephron Pharmaceuticals Corporation'. National Drug Code (NDC) number for Sterile Water is 0487-6105. This drug is available in dosage form of Injection. 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: | 0487-6105 |
| 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: | Sterile Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nephron Pharmaceuticals Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | ANDA |
| 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: | 07 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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. |
| Application Number: | ANDA211222 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Nephron Pharmaceuticals Corporation
|
| 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. |
| 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 |
|---|
| 0487-6105-01 | 30 VIAL, PLASTIC in 1 CARTON (0487-6105-01) / 5 mL in 1 VIAL, PLASTIC | 16 Jun, 2021 | 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 sterile water water water
Drug Interactions:
Some drugs for injection may be incompatible in a given vehicle, when combined in the same vehicle, or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for withdrawal from the container. when diluting or dissolving drugs, mix thoroughly and use promptly. do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. do not use unless the solution is clear. do not reuse single-dose containers. discard unused portion.
Indications and Usage:
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.
Warnings:
Intravenous administration of sterile water for injection without a solute may result in hemolysis.
Dosage and Administration:
The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose, and route of administration as recommended by the manufacturer. this parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. please refer to instructions for use for administration instructions.
Contraindications:
Sterile water for injection must be made approximately isotonic prior to use.
Adverse Reactions:
Reactions which may occur because of this solution, added drugs, or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis, or phlebitis extending from the site of injection and extravasation. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
Drug Interactions:
Some drugs for injection may be incompatible in a given vehicle, when combined in the same vehicle, or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for withdrawal from the container. when diluting or dissolving drugs, mix thoroughly and use promptly. do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. do not use unless the solution is clear. do not reuse single-dose containers. discard unused portion.
Use in Pregnancy:
Animal reproduction studies have not been conducted with sterile water for injection. it is not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. sterile water for injection with additives should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Safety and effectiveness have been established in pediatric patients. however, in neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance.
Overdosage:
Use only as a diluent or solvent. this parenteral preparation is unlikely to pose a threat of fluid overload, except possibly in neonates or very small infants. in the event these should occur, re-evaluate the patient and institute appropriate corrective measures. see warnings, precautions and adverse reactions.
Description:
This preparation is designed solely for parenteral use, only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. sterile water for injection, usp is a sterile, nonpyrogenic preparation of water for injection, which contains no bacteriostat, antimicrobial agent or added buffer, and is supplied only in single-dose containers to dilute or dissolve drugs for injection. for intravenous injection, dissolve sufficient solute to make an approximately isotonic solution. water for injection, usp is chemically designated h2o. ph 5.0 to 7.0. the plastic single-dose vial is fabricated from polypropylene resin. the plastic vials feature a twist-off cap which, when removed, allows access to a luer-lock fitting for connection to a luer-lock syringe. the twist-off cap is a one-time use tamper evident feature, and the container vial cannot be reclosed once the cap is removed.
Clinical Pharmacology:
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na+) plays a major role in maintaining physiologic equilibrium. the small volume of fluid provided by sterile water for injection when used only as a pharmaceutical aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.
How Supplied:
Sterile water for injection, usp is supplied in 5 ml vials, packaged in cartons as follows: ndc 0487-6105-01, 30 individual 5 ml single-dose luer-lock vials. discard unused portion. each vial is made from a polypropylene (pp) resin. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.]
Package Label Principal Display Panel:
Sleeve carton