| Drug NDC: | 0264-3200 |
| 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: | Plenamine |
| 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: | Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | B. Braun Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | 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: | ALANINE - 2.17 g/100mL ARGININE - 1.47 g/100mL ASPARTIC ACID - 434 mg/100mL GLUTAMIC ACID - 749 mg/100mL GLYCINE - 1.04 g/100mL HISTIDINE - 894 mg/100mL ISOLEUCINE - 749 mg/100mL LEUCINE - 1.04 g/100mL LYSINE ACETATE - 1.18 g/100mL METHIONINE - 749 mg/100mL Load more... PHENYLALANINE - 1.04 g/100mL PROLINE - 894 mg/100mL SERINE - 592 mg/100mL THREONINE - 749 mg/100mL TRYPTOPHAN - 250 mg/100mL TYROSINE - 39 mg/100mL VALINE - 960 mg/100mL |
| 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 Category: | ANDA |
| 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 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 25 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: | ANDA091112 |
| 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. | |
| Manufacturer Name: | B. Braun Medical Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| RxCUI: | 800584 1601982 |
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000175780 M0000922 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 94ZLA3W45F 42HK56048U HG18B9YRS7 9DLQ4CIU6V AE28F7PNPL 2ZD004190S 3KX376GY7L 4QD397987E GMW67QNF9C TE7660XO1C Load more... TTL6G7LIWZ 8DUH1N11BX 30KYC7MIAI OF5P57N2ZX 47E5O17Y3R 452VLY9402 04Y7590D77 |
| 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 EPC: | Amino Acid [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 CS: | Amino Acids [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Amino Acid [EPC] Amino Acids [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 0264-3200-55 | 6 CARTON in 1 CASE (0264-3200-55) / 1 BOTTLE, GLASS in 1 CARTON / 1000 mL in 1 BOTTLE, GLASS | 30 Jan, 2015 | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.