| Drug NDC: | 64661-650 |
| 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: | Enbrace Hr |
| 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: | Levomefolate Magnesium, Leucovorin, Folic Acid, Ferrous Cysteine Glycinate, Magnesium Ascorbate, Zinc Ascorbate, Cocarboxylase, Flavin Adenine Dinucleotide, Nadh, Pyridoxal Phosphate Anhydrous, Cobamamide, Betaine, Magnesium L-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, And Phosphatidyl Serine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Jaymac Pharma |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Capsule, Delayed Release Pellets |
| 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: | 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM - 6.4 mg/1 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM - 800 ug/1 BETAINE - 500 ug/1 COBAMAMIDE - 50 ug/1 COCARBOXYLASE - 25 ug/1 FERROUS CYSTEINE GLYCINATE - 13.6 mg/1 FLAVIN ADENINE DINUCLEOTIDE - 25 ug/1 FOLIC ACID - 1 mg/1 LEUCOVORIN - 2.5 mg/1 LEVOMEFOLATE MAGNESIUM - 5.23 mg/1 Load more... MAGNESIUM ASCORBATE - 24 mg/1 MAGNESIUM L-THREONATE - 1 mg/1 NADH - 25 ug/1 PHOSPHATIDYL SERINE - 12 mg/1 PYRIDOXAL PHOSPHATE ANHYDROUS - 25 ug/1 ZINC ASCORBATE - 1 mg/1 |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| 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: | 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: | 12 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 21 Jan, 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. | |
| 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: | Jaymac Pharma |
| 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: | 0364661650302 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000175804 N0000175805 N0000178369 M0008658 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 6WJM73T46K 9ABD9DRK7B 3SCV180C9W F0R1QK73KB Q57971654Y 8B4OP7RK5N ZC44YTI8KK 935E97BOY8 Q573I9DVLP 1VZZ62R081 Load more... 0N1G678593 1Y26ZZ0OTM 4J24DQ0916 394XK0IH40 F06SGE49M6 9TI35313XW |
| 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 MOA: | Methylating Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Methylating Agent [EPC] Folate Analog [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: | Folic Acid [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: | Ascorbic Acid [CS] Folate Analog [EPC] Folic Acid [CS] Methylating Activity [MoA] Methylating Agent [EPC] Vitamin C [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 64661-650-30 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30) | 12 Aug, 2011 | 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.