Cystografin
Diatrizoate Meglumine
Bracco Diagnostics Inc
Human Prescription Drug
NDC 0270-0149Cystografin also known as Diatrizoate Meglumine is a human prescription drug labeled by 'Bracco Diagnostics Inc'. National Drug Code (NDC) number for Cystografin is 0270-0149. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Cystografin drug includes Diatrizoate Meglumine - 300 mg/mL . The currest status of Cystografin drug is Active.
Drug Information:
| Drug NDC: | 0270-0149 |
| 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: | Cystografin |
| 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: | Diatrizoate Meglumine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bracco Diagnostics 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: | DIATRIZOATE MEGLUMINE - 300 mg/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: | 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: | 03 Nov, 1970 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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: | NDA010040 |
| 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: | BRACCO DIAGNOSTICS 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. |
| UNII: | 3X9MR4N98U
|
| 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: | 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 |
|---|
| 0270-0149-57 | 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE | 03 Nov, 1970 | N/A | No |
| 0270-0149-60 | 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE | 03 Nov, 1970 | 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:
Cystografin diatrizoate meglumine diatrizoate meglumine diatrizoic acid edetate disodium
Indications and Usage:
Indication cystografin is indicated for retrograde cystourethrography.
Warnings:
Warnings severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents. a history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.
Dosage and Administration:
Dosage and administration preparation of the patient: appropriate preparation is desirable for optimal results. a laxative the night before the examination and a low residue diet the day before the procedure are recommended. dosage: the dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 ml depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 ml may be used if the bladder capacity allows. best results are obtained when the bladder is filled with the contrast agent. if desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below. administration: after sterile catheterization, the bladder should be filled to capacity with cystografin using a suitable sterile administration set. care should be taken to avoid using excessive pressure. the presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full. radiogr
Read more...aphy: the commonly employed radiographic techniques should be used. a scout film is recommended before the contrast agent is administered. dilution table use diluted solutions immediately 100 ml bottle sterile water or sterile saline added % diatrizoate meglumine w/v % organically bound iodine w/v total volume 0 ml 30.0 14.1 100 ml 25 ml 24.0 11.3 125 ml 50 ml 20.0 9.4 150 ml 67 ml 18.0 8.5 167 ml 300 ml bottle sterile water or sterile saline added 0 ml 30.0 14.1 300 ml 50 ml 25.7 12.1 350 ml
Contraindications:
Contraindications this preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
Adverse Reactions:
Adverse reactions retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. if intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. hypersensitivity or anaphylactoid reactions may occur. severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. endocrine: thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. some patients were treated for hypothyroidism.
Description:
Description cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. each ml provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. each ml of solution also contains approximately 141 mg organically bound iodine. at the time of manufacture, the air in the container is replaced by nitrogen. the preparation should be protected from strong light.
How Supplied:
How supplied cystografin (diatrizoate meglumine injection usp 30%) is available in 200 ml and 400 ml bottles containing 100 ml and 300 ml of cystografin respectively with sufficient capacity for dilution up to 167 ml and 350 ml respectively. storage store at 20-25°c (68-77°f) [see usp]. protect from light. also available cystografin dilute (diatrizoate meglumine injection usp 18%) is also available, as a 300 ml fill in a 400 ml bottle.
Package Label Principal Display Panel:
Cystografin 100 ml label ndc 0270-0149-60 100 ml label