Sodium Acetate
Hospira, Inc.
Human Prescription Drug
NDC 0409-7299Sodium Acetate is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Sodium Acetate is 0409-7299. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Sodium Acetate drug includes Sodium Acetate Anhydrous - 3.28 g/20mL . The currest status of Sodium Acetate drug is Active.
Drug Information:
| Drug NDC: | 0409-7299 |
| 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: | Sodium Acetate |
| 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: | Sodium Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hospira, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution, Concentrate |
| 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: | SODIUM ACETATE ANHYDROUS - 3.28 g/20mL
|
| 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: | NDA |
| 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 Mar, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | NDA018893 |
| 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: | Hospira, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1859490
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | NVG71ZZ7P0
|
| 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. |
| Pharmacologic Class: | Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0409-7299-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7299-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-7299-45) | 05 Mar, 2014 | 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:
Sodium acetate sodium acetate sodium acetate anhydrous sodium cation acetate ion water acetic acid
Indications and Usage:
Indications and usage sodium acetate injection, usp 40 meq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
Warnings:
Warnings sodium acetate injection, usp 40 meq must be diluted before use. to avoid sodium overload and water retention, infuse sodium-containing solutions slowly. solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. in patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. the intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhy
Read more...dration, congested states or pulmonary edema. excessive administration of potassium free solutions may result in significant hypokalemia. warning: this product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration.
Dosage and Administration:
Dosage and administration sodium acetate injection, usp 40 meq is administered intravenously only after dilution in a larger volume of fluid. the dose and rate of administration are dependent upon the individual needs of the patient. serum sodium should be monitored as a guide to dosage. using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (meq) of sodium (na + ) with an equal number of acetate (ch 3 coo - ). parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. see precautions .
Contraindications:
Contraindications sodium acetate injection, usp 40 meq is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions:
Adverse reactions sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. see warnings and precautions .
Overdosage:
Overdosage in the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary. see warnings , precautions and adverse reactions .
Description:
Description sodium acetate injection, usp 40 meq (2 meq/ml) is a sterile, nonpyrogenic, concentrated solution of sodium acetate in water for injection. the solution is administered, after dilution, by the intravenous route as an electrolyte replenisher. it must not be administered undiluted. each 20 ml contains 3.28 g of sodium acetate (anhydrous) which provides 40 meq each of sodium (na + ) and acetate (ch 3 coo - ). the solution contains no bacteriostat, antimicrobial agent or added buffer. may contain acetic acid for ph adjustment; the ph is 6.5 (6.0 to 7.0). the osmolar concentration is 4 mosmol/ml (calc). the solution is intended as an alternative to sodium chloride to provide sodium ion (na + ) for addition to large volume infusion fluids for intravenous use. sodium acetate, usp (anhydrous) is chemically designated ch 3 coona, a hygroscopic powder very soluble in water. the semi-rigid container is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. the container requires no vapor barrier to maintain the proper drug concentration.
Clinical Pharmacology:
Clinical pharmacology sodium is the principal cation of extracellular fluid. it comprises more than 90% of total cations at its normal plasma concentration of approximately 140 meq/liter. the sodium ion exerts a primary role in controlling total body water and its distribution. acetate (ch 3 coo - ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (hco 3 - ) by metabolic conversion in the liver. this has been shown to proceed readily, even in the presence of severe liver disease.
How Supplied:
How supplied sodium acetate injection, usp 40 meq (2 meq/ml) is supplied as follows: unit of sale concentration each ndc 0409-7299-25 tray containing 25 units 40 meq/20 ml (2 meq/ml) ndc 0409-7299-45 single-dose fliptop vial each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] distributed by hospira, inc., lake forest, il 60045 usa novaplus is a registered trademark of vizient, inc. lab-1191-3.0 revised: 11/2020 logo
Package Label Principal Display Panel:
Principal display panel - 20 ml vial label 20 ml single-dose ndc 0409-7299-45 sodium acetate injection, usp 40 meq/20 ml (2 meq/ml) for intravenous use caution: must be diluted novaplus ⢠dist. by hospira, inc. lake forest, il 60045 usa principal display panel - 20 ml vial label
Principal display panel - 20 ml vial tray ndc 0409-7299-25 contains 25 of ndc 0409-7299-45 sodium acetate injection, usp 40 meq/20 ml (2 meq/ml) for intravenous use 20 ml single-dose rx only caution: must be diluted novaplus ⢠principal display panel - 20 ml vial tray