Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic)
Anticoagulant Citrate Phosphate Dextrose (cpd) Solution And Adsol Preservation Solution
Fenwal, Inc.
Human Prescription Drug
NDC 0942-6431Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) also known as Anticoagulant Citrate Phosphate Dextrose (cpd) Solution And Adsol Preservation Solution is a human prescription drug labeled by 'Fenwal, Inc.'. National Drug Code (NDC) number for Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) is 0942-6431. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) drug includes . The currest status of Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) drug is Active.
Drug Information:
| Drug NDC: | 0942-6431 |
| 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: | Adsol Red Cell Preservation Solution System In Plastic Container (pl 146 Plastic) |
| 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 (cpd) Solution And Adsol Preservation Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fenwal, Inc. |
| 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: | 01 Mar, 2007 |
| 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. |
| Application Number: | BN811104 |
| 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: | Fenwal, 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: | |
| 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 |
|---|
| 0942-6431-02 | 1 KIT in 1 KIT (0942-6431-02) * 70 mL in 1 BAG * 110 mL in 1 BAG | 01 Mar, 2007 | 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:
Adsol red cell preservation solution system in plastic container (pl 146 plastic) anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution cpd citrate phosphate dextrose trisodium citrate dihydrate anhydrous citric acid dextrose monohydrate anhydrous dextrose anhydrous citric acid anhydrous citric acid sodium phosphate, monobasic, monohydrate phosphate ion sodium hydroxide water adsol red cell preservation solution system adsol red cell preservation solution dextrose monohydrate anhydrous dextrose sodium chloride sodium cation mannitol mannitol adenine adenine water
Package Label Principal Display Panel:
Package/label display panel code 4r3429 15 units fresenius kabi fenwal blood-pack units double anticoagulant citrate phosphate dextrose solution, usp (cpd); satellite container with adsol red cell preservation solution for the collection and processing of 500 ml blood y-sampling site, 16 ga. ultra thin wall fenwal highflo needle rx only each unit consists of a primary container with 70 ml of cpd solution containing 1.84 g sodium citrate (dihydrate) usp, 1.78 g dextrose (monohydrate) usp, 209 mg citric acid (anhydrous) usp, 155 mg monobasic sodium phosphate (monohydrate) usp, ph may have been adjusted with sodium hydroxide; one satellite container with 110 ml of adsol red cell preservation solution containing 2.42 g dextrose (monohydrate) usp, 990 mg sodium chloride usp, 825 mg mannitol usp, 30 mg adenine usp; one empty 400 ml transfer-pack container. sterile, non-pyrogenic fluid path. see instructions for use. single use only. store at controlled room temperature (refer to direction insert). ⢠open pouch by tearing across at notch. ⢠direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. ⢠unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture, provided: i) units are not removed from foil pouch, or ii) unused units removed from foil pouch are returned to the foil pouch within 12 hours. units may be removed from the pouch and returned only once. ⢠units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). units out of the foil pouch for longer than 96 hours must be discarded. manufacturer fresenius kabi ag 61346 bad homburg / germany www.fresenius-kabi.com made in us 47-23-13-539 rev: a 4r3429pack