Indigo Carmine
American Regent, Inc.
Human Prescription Drug
NDC 0517-0375Indigo Carmine is a human prescription drug labeled by 'American Regent, Inc.'. National Drug Code (NDC) number for Indigo Carmine is 0517-0375. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Indigo Carmine drug includes Indigotindisulfonate Sodium - 8 mg/mL . The currest status of Indigo Carmine drug is Active.
Drug Information:
| Drug NDC: | 0517-0375 |
| 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: | Indigo Carmine |
| 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: | Indigo Carmine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Regent, 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: | INDIGOTINDISULFONATE SODIUM - 8 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
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: | 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: | 30 Sep, 1990 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 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: | American Regent, 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. |
| UPC: | 0305170375058
|
| UPC stands for Universal Product Code. |
| UNII: | D3741U8K7L
|
| 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: | Diagnostic Dye [EPC]
Dyes [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 |
|---|
| 0517-0375-05 | 5 AMPULE in 1 BOX (0517-0375-05) / 1 mL in 1 AMPULE (0517-0375-01) | 30 Sep, 1990 | 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:
Indigo carmine indigo carmine indigotindisulfonate sodium indigotindisulfonic acid citric acid monohydrate sodium citrate water
Indications and Usage:
Indications and usage originally employed as a kidney function test, the chief application of indigo carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization.
Warnings:
Warnings an occasional idiosyncratic drug reaction may occur. a mild pressor effect may be encountered in some patients.
Dosage and Administration:
Dosage and administration indigo carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. the intravenous method is preferred because a 5 ml injection is sufficient. a lesser dosage in infants, children and underweight patients will prevent skin coloration. since precipitation of indigotindisulfonate sodium may occur, indigo carmine solution must not be diluted prior to injection or injected with infusion assemblies which were used with other solutions. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. note : since indigo carmine is a dark blue solution, visual inspection for particulate matter prior to use may not be possible. to ensure that the withdrawn solution contains no particulates, 5 micron filter straws/filter needles must be used when withdrawing contents of amp
Read more...ules 1 . the 5 micron nylon mesh filter is suitable for withdrawing the drug product, indigo carmine. 1 ashp guidelines on compounding sterile preparations protect from light. indigo carmine should be stored in the dark, away from direct light, preferably in the original package. store at 20º to 25º c (68º to 77º f); excursions permitted to 15º to 30º c (59º to 86º f) (see usp controlled room temperature).
Contraindications:
Contraindications indigo carmine is contraindicated in patients who have previously experienced an adverse reaction following its use.
Adverse Reactions:
Adverse reactions see warnings .
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with indigotindisulfonate sodium injection. it is also not known whether indigotindisulfonate sodium injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. indigotindisulfonate sodium injection should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when indigo carmine is administered to a nursing woman.
Overdosage:
Overdosage there are no data available describing the signs, symptoms or laboratory findings accompanying overdosage. no discernible symptoms of toxicity have been observed in mice with an intravenous dose of 200 mg/kg. after intravenous administration the ld 50 was established at 300 mg/kg in mice.
Description:
Description each ml contains: indigotindisulfonate sodium 8 mg, water for injection q.s. ph adjusted, when necessary, with citric acid and/or sodium citrate. sterile, nonpyrogenic. sufficient indigo carmine is contained in each 5 ml ampule to permit accurate withdrawal and administration of the full dose. it gives a deep blue solution when dissolved in water. the structural formula is: 0aade973-figure-01
Clinical Pharmacology:
Clinical pharmacology indigo carmine is excreted largely by the kidneys, retaining its blue color during passage through the body. elimination of the dye begins soon after injection, appearing in the urine within 10 minutes in average cases. the biological half-life is 4 to 5 minutes following intravenous injection. larger quantities are necessary when intramuscular injection is employed. appearance time and elimination are delayed following intramuscular injection.
How Supplied:
How supplied indigo carmine injection ndc 0517-0375-05 5 ml ampules packaged in boxes of 5 american regent, inc. shirley, ny 11967 in0375 rev. 2/17
Package Label Principal Display Panel:
Package label.principal display panel principal display panel - 5 ml container ndc 0517-0375-01 indigo carmine injection (indigotindisulfonate sodium injection, usp) 0.8% solution 5 ml ampule for iv or im use rx only american regent, inc. shirley, ny 11967 principal display panel â 5 ml carton indigo carmine injection (indigotindisulfonate sodium injection, usp) 0.8% solution ndc 0517-0375-05 5 x 5 ml ampules rx only for intravenous or intramuscular use each ml contains: indigotindisulfonate sodium 8 mg, water for injection q.s. ph adjusted, when necessary, with citric acid and/or sodium citrate. sterile, nonpyrogenic. warning: protect from light. store at 20º to 25ºc (68º to 77ºf); excursions permitted to 15 to 30 c (59 to 86 f) (see usp controlled room temperature). directions for use: see package insert. american regent, inc. shirley, ny 11967 rev. 2/17 container label carton labeling
Serialization label serialization label