Sterile Water

Water


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-185
Sterile Water also known as Water is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sterile Water is 63323-185. 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: 63323-185
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: Fresenius Kabi Usa, Llc
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: 05 Sep, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 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: ANDA088400
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:Fresenius Kabi USA, LLC
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:0363323185084
0363323185077
0363323185046
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
63323-185-0525 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)30 Apr, 2022N/ANo
63323-185-1025 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07)05 Sep, 2000N/ANo
63323-185-2025 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)05 Sep, 2000N/ANo
63323-185-5025 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)05 Sep, 2000N/ANo
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

Drug Interactions:

Drug interactions some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for single or multiple entry and withdrawal from all containers. 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 and seal intact. do not reuse single-dose containers. discard unused portion.

Indications and Usage:

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:

Warnings intravenous administration of sterile water for injection without a solute may result in hemolysis.

Dosage and Administration:

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.

Contraindications:

Contraindications sterile water for injection must be made approximately isotonic prior to use.

Adverse Reactions:

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:

Drug interactions some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for single or multiple entry and withdrawal from all containers. 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 and seal intact. do not reuse single-dose containers. discard unused portion.

Use in Pregnancy:

Pregnancy animal reproduction studies have not been conducted with sterile water for injection. it is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sterile water for injection with additives should be given to a pregnant woman only if clearly needed.

Pediatric Use:

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:

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:

Description this preparation is designed solely for parenteral use only after addition to 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 iv injection, add sufficient amount to a solute to make an approximately isotonic solution. ph 5.0 to 7.0. water for injection, usp is chemically designated h 2 o.

Clinical Pharmacology:

Clinical pharmacology water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water 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, usp when used only as a pharmaceutic 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:

How supplied product code unit of sale volume each 918510 ndc 63323-185-10 unit of 25 10 ml in a 10 ml vial ndc 63323-185-07 10 ml single dose vial 918520 ndc 63323-185-20 unit of 25 20 ml in a 20 ml vial ndc 63323-185-08 20 ml single dose vial 918550 ndc 63323-185-50 unit of 25 50 ml in a 50 ml vial ndc 63323-185-09 50 ml single dose vial 187100 ndc 65219-187-10 unit of 25 100 ml in a 100 ml vial ndc 65219-187-01 100 ml single dose vial 18505 ndc 63323-185-05 unit of 25 5 ml in a 6 ml vial ndc 63323-185-04 5 ml single dose vial packaged in a plastic vial. vials are packaged 25 vials per tray. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. single dose use. no preservative added. unused portion of vial should be discarded. use only if solution is clear and seal intact.

Package Label Principal Display Panel:

Package label - principal display - sterile water - 10 ml single dose vial label ndc 63323-185-07 918510 sterile water for injection, usp for drug diluent use only rx only 10 ml single dose vial package label - principal display - sterile water - 10 ml single dose vial label

Package label – principal display – sterile water – 10 ml single dose vial tray label ndc 63323-185-10 918510 sterile water for injection, usp for drug diluent use only rx only 10 ml single dose vial 25 vials package label – principal display – sterile water – 10 ml single dose vial tray label

Package label – principal display – sterile water – 20 ml single dose vial label ndc 63323-185-08 918520 sterile water for injection, usp for drug diluent use only rx only 20 ml single dose vial package label – principal display – sterile water – 20 ml single dose vial label

Package label – principal display – sterile water – 20 ml single dose vial tray label ndc 63323-185-20 918520 sterile water for injection, usp for drug diluent use only rx only 20 ml single dose vial 25 vials package label – principal display – sterile water – 20 ml single dose vial tray label

Package label – principal display – sterile water – 50 ml single dose vial label ndc 63323-185-09 918550 sterile water for injection, usp for drug diluent use only rx only 50 ml single dose vial package label – principal display – sterile water – 50 ml single dose vial label

Package label – principal display – sterile water – 50 ml single dose vial tray label ndc 63323-185-50 918550 sterile water for injection, usp for drug diluent use only rx only 50 ml single dose vial 25 vials package label – principal display – sterile water – 50 ml single dose vial tray label

Package label - principal display - sterile water - 5 ml single dose vial label ndc 63323-185-04 18505 sterile water for injection, usp for drug diluent use only rx only 5 ml single dose vial package label - principal display - sterile water - 5 ml single dose vial label

Package label - principal display - sterile water - 5 ml single dose tray label ndc 63323-185-05 18505 sterile water for injection, usp for drug diluent use only rx only 5 ml single dose vial 25 vials package label - principal display - sterile water - 5 ml single dose tray label


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