Leucoflex Cgp
Anticoagulant Citrate Phosphate Dextrose Solution With Additive Solution As-1
Maco Productions
Human Prescription Drug
NDC 14498-002Leucoflex Cgp also known as Anticoagulant Citrate Phosphate Dextrose Solution With Additive Solution As-1 is a human prescription drug labeled by 'Maco Productions'. National Drug Code (NDC) number for Leucoflex Cgp is 14498-002. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Leucoflex Cgp drug includes . The currest status of Leucoflex Cgp drug is Active.
Drug Information:
| Drug NDC: | 14498-002 |
| 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: | Leucoflex Cgp |
| 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: | Anticoagulant Citrate Phosphate Dextrose Solution With Additive Solution As-1 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Maco Productions |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 31 May, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| 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: | BN040083 |
| 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: | Maco Productions
|
| 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: | |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 14498-002-01 | 1 KIT in 1 KIT (14498-002-01) * 110 mL in 1 BAG * 70 mL in 1 BAG | 31 May, 2013 | 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:
Leucoflex cgp anticoagulant citrate phosphate dextrose solution with additive solution as-1 anticoagulant citrate phosphate dextrose solution anticoagulant citrate phosphate dextrose solution sodium citrate anhydrous citric acid dextrose monohydrate anhydrous dextrose anhydrous citric acid anhydrous citric acid sodium phosphate, monobasic, monohydrate phosphate ion additive solution as-1 additive solution as-1 dextrose monohydrate anhydrous dextrose sodium chloride sodium cation mannitol mannitol adenine adenine
Warnings:
Warning avoid contact with sharp objects. do not use if the overwrap or blood bag system shows any signs of deterioration. do not use if the solutions are not clear. dispose of all system components that have been contaminated with blood in a biohazard container as per your institution's sop. dispose of all sharps as per your institution's sop.
Description:
Description the leucoflex cgp product consists of a blood collection system with 70ml of cpd for the collection of 500±50ml of blood and 100ml of as-1 additive solution. they are supplied with sterile, non-pyrogenic fluid pathways. the product as supplied includes an in-line leukocyte reduction filter known as leucoflex cgp, storage containers for blood components and tubing, a sample diversion pouch (bactivam), a vacuum tube adapter (vacuvam), and a protective shield for the used needle (secuvam). representative product drawing representativeproductdrawing
Package Label Principal Display Panel:
Labels bag 1 anticoagulant citrate phosphate dextrose solution, usp; bag 2 additive solution as-1; overwrap; carton anticoagulant citrate phosphate dextrose solution, usp - bag 1 label additive solution as-1 - bag 2 label overwrap label carton label bag1labelcpd bag2labelas1 overwraplabel cartonlabel