EnBrace HR
- Product NDC
- 64661-650
- 11-digit product format
- 646610650
- Labeler code
- 64661
- Product ID
- 64661-650_f9057685-e197-4b3d-a632-2d6263f606b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary 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
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Jaymac Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-08-12
- Substance
- 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; BETAINE; COBAMAMIDE; COCARBOXYLASE; FERROUS CYSTEINE GLYCINATE; FLAVIN ADENINE DINUCLEOTIDE; FOLIC ACID; LEUCOVORIN; LEVOMEFOLATE MAGNESIUM; MAGNESIUM ASCORBATE; MAGNESIUM L-THREONATE; NADH; PHOSPHATIDYL SERINE; PYRIDOXAL PHOSPHATE ANHYDROUS; ZINC ASCORBATE
- Active strength
- 6.4; 800; 500; 50; 25; 13.6; 25; 1; 2.5; 5.23; 24; 1; 25; 12; 25; 1 mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
- Pharmacologic classes
- Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folate Analog [EPC], Folic Acid [CS], Folic Acid [CS], Methylating Activity [MoA], Methylating Agent [EPC], Vitamin C [EPC], Vitamin C [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EnBrace HR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| 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 |
| 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 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6WJM73T46K, 9ABD9DRK7B, 3SCV180C9W, F0R1QK73KB, Q57971654Y, 8B4OP7RK5N, ZC44YTI8KK, 935E97BOY8, Q573I9DVLP, 1VZZ62R081, 0N1G678593, 1Y26ZZ0OTM, 4J24DQ0916, 394XK0IH40, F06SGE49M6, 9TI35313XW |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 31adef49-84cb-4c51-b122-69e924e10ea3 | Product name | 4 | 20240827 |
| df40773e-fe5a-474c-8d32-d19c7094e396 | Product name | 2 | 20240813 |
| cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2 | Product name | 1 | 20231116 |
| 38866763-6a8e-4096-95c3-082a000c243d | Product name | 1 | 20230809 |
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
| 7ce39568-aceb-b33a-23ed-c4964cdcf486 | Product name | 2 | 20210211 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| ddff2484-d547-4e6a-bacd-95eef7e31c64 | Product name | 2 | 20180807 |
| 90854981-3820-4bc4-a1d3-666ec508941c | Product name | 2 | 20180214 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 6c712ad1-eecf-448f-84d9-5c0c307a7112 | Product name | 1 | 20161130 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64661-650-30 | EnBrace HR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64661-650-30 | EA - Each | 64661-650 | bd6a403d-a4a2-41c5-aaa0-2ba11ac3f72d | 1 | 2015-06-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64661-650 | ENBRACE HR (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) CAPSULE, DELAYED RELEASE PELLETS [JAYMAC PHARMA] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250103_6f14fa40-97ab-4ec5-b66b-793d6d1abac9.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64661-650-30 | 64661065030 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30) | 2011-08-12 | 0000-00-00 | No | No | Current |