E-z-disk
Barium Sulfate
E-z-em, Inc.
Human Prescription Drug
NDC 10361-778E-z-disk also known as Barium Sulfate is a human prescription drug labeled by 'E-z-em, Inc.'. National Drug Code (NDC) number for E-z-disk is 10361-778. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in E-z-disk drug includes Barium Sulfate - 700 mg/1 . The currest status of E-z-disk drug is Active.
Drug Information:
| Drug NDC: | 10361-778 |
| 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: | E-z-disk |
| 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: | Barium Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | E-z-em, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | BARIUM SULFATE - 700 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 01 Feb, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | E-Z-EM, 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. |
| NUI: | N0000180185
N0000010258
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 25BB7EKE2E
|
| 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 MOA: | X-Ray Contrast Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Radiographic Contrast Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Radiographic Contrast Agent [EPC]
X-Ray Contrast Activity [MoA]
|
| 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 |
|---|
| 10361-778-31 | 100 TABLET in 1 BOTTLE, GLASS (10361-778-31) | 01 Feb, 2009 | 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:
E-z-disk barium sulfate barium sulfate barium sulfate round, flat 778;ezem
Indications and Usage:
Indications and usage e-z-disk is indicated for use in radiography of the esophagus, for detection of esophageal strictures.
Warnings:
Warnings rarely, severe allergic reactions of an anaphylactoid nature have been reported following administration of barium sulfate contrast agents. appropriate facilities and trained personnel should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.
General Precautions:
General diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. a history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. use with caution in patients with complete or nearly complete esophageal or gastric obstruction.
Dosage and Administration:
Dosage and administration this tablet is most useful in patients experiencing dysphagia, particularly in those whose findings are deemed inconclusive by conventional methods. the problems associated with obtaining satisfactory films exhibiting complete filling of the pharynx and cricopharyngeal area make for difficult diagnosis in this region. in such cases, failure of the tablet to freely pass this site may indicate significant esophageal disease as cause of the symptoms, and may warrant further videographic studies. the patient should be instructed to swallow one tablet intact, with the aid of one or two swallows of water, just prior to fluoroscopic examination. note: using a tablet of known diameter (½ inch) not only illustrates the presence of a significant narrowing of the esophagus, but also provides a simple technique to measure the lumen at the site of the stricture. the most routinely used esophagoscope has external diameter of 36 french, and thus a tablet of corresponding
Read more...half-inch diameter was selected. the actual diameter (in inches) of the narrow site is one-half the ratio of its measure value on the film to the measure of the tablet upon swallowing the tablet, the patient experiences no significant discomfort, and fluid passes around the tablet without difficulty.
Contraindications:
Contraindications barium sulfate products for radiographic procedures should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate formulations.
Adverse Reactions:
Adverse reactions adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping accompanying the use of barium sulfate suspensions are infrequent, usually mild, and generally do not occur with this product. procedural complications are rare, but may include aspiration pneumonitis, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. it is of the utmost importance to be completely prepared to treat any such occurrence.
Use in Pregnancy:
Usage in pregnancy radiation is known to cause harm to the unborn fetus exposed in utero. therefore, radiographic procedures should be used only when, in the judgment of the physician, their use is deemed essential to the welfare of the pregnant patient.
Description:
Description e-z-disk⢠is an oral solid radiographic contrast agent. each tablet contains 700 mg of barium sulfate and is ½ inch in diameter. the active ingredient is barium sulfate and its structural formula is baso 4 . barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. its aqueous suspensions are neutral to litmus. it is practically insoluble in water, solutions of acids and alkalies, and organic solvents. each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, corn starch, croscarmellose sodium and confectionerâs sugar.
Clinical Pharmacology:
Clinical pharmacology barium sulfate, due to its high molecular density is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. barium sulfate is biologically inert and therefore is not absorbed or metabolized by the body, and is eliminated unchanged from the body. absorption and metabolism e-z-disk tablets disintegrate within 30 minutes after ingestion, and the fragments are eliminated with the feces without absorption of the barium sulfate. a brief delay in transit may sometimes be seen in elderly patients, particularly above the hiatus, or at the level of the aortic arch. in such instances, a sip of water is sufficient to carry the tablet down the esophagus.
How Supplied:
How supplied e-z-disk⢠is a white tablet with ezem on one side and 778 on the other side and is supplied in the following manner: bottles of 100 ½-inch diameter, flat-sided tablets; cat. no. 778, ndc 10361-778-31 storage store product at usp controlled room temperature, 20 to 25°c (68 to 77°f). protect from moisture.
Information for Patients:
Information for patients before administration of this product, patients receiving barium sulfate diagnostic agents should be instructed to: inform their physician if they are pregnant. inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see precautions-general ). inform their physician about any other medications they are currently taking.
Package Label Principal Display Panel:
E-z-disk tablets ndc: 10361-778-31 e-z-disk-unit-label