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-DOCOSAHEXANOY 5.23 mg; 2.5 mg; 1 mg; 13.6 mg; 24 mg; 1 mg; 25 ug; 25 ug; 25 ug Capsule, Delayed Release Pellets, 30-count — NDC 64661-650-30 (Billing 64661-0650-30)
This is a package of 30 capsules of 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-DOCOSAHEXANOY 5.23 mg; 2.5 mg; 1 mg; 13.6 mg; 24 mg; 1 mg; 25 ug; 25 ug; 25 ug Capsule, Delayed Release Pellets from Jaymac Pharmaceuticals, LLC, marketed since Aug 2011 and currently FDA-listed; retail pharmacies pay about $4.48 per capsule (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 64661-650-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 64661 labeler · 650 product · 30 package
- Package marketed since
- Aug 12, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6466165030 2
- Medicaid fills, this package
- 11,343 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 074012
- GCN: 38525
- HICL (First Databank): 042005
- AHFS class code: 20:04.04.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
EnBrace HR is an oral delayed-release capsule containing multiple B vitamins, minerals, and phospholipid compounds. The product includes folate derivatives (levomefolate magnesium, leucovorin, and folic acid) along with B vitamin cofactors like pyridoxal phosphate, cobamamide (B12), and flavin adenine dinucleotide, which are typically involved in energy metabolism and nerve function support. It also contains iron, magnesium, zinc, and specialized phospholipid compounds. This is an unapproved drug product marketed without an FDA-approved application.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.479 | $134.37 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $4.63 | $138.84 / 30 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 64661-0650-30 You're viewing this Main listing | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE | 2011-08-12 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| EnBrace HR 5.23 mg/1; 2.5 mg/1; 1 mg/1; 13.6 mg/1; 24 mg/1; 1 mg/1; 25 ug/1; 25 ug/1; 25 ugthis 64661-0650-30 | Jaymac | 30 capsules | $4.479 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 6PQP1V1B6O
A natural yellow-orange colorant derived from seeds of the achiote plant. It gives medicines their color and is used as a food-safe dye in tablets and capsules.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 834K0WOS5G
A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
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UNII U71XL721QK
Piperine is an alkaloid compound extracted from black pepper. It's used in some formulations as a flavor enhancer and potential absorption promoter to help the body take in active ingredients more effectively.
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UNII EJ27X76M46
Ubidecarenone is a naturally occurring compound found in cells that helps produce energy. In medicines, it acts as an antioxidant and may help stabilize the product while supporting cellular function in the body.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
7 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Jaymac Pharmaceuticals, LLC labeler code 64661
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS: EnBrace HR ® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate. Requirements of vitamin B 9 and/or vitamin B 12 in excess of normal due to pregnancy can usually be met with oral supplementation.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION : The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs. As a general rule reticulocyte plasma count, folate and vitamin B 12 status must be obtained prior to treatment. Do not exceed the recommended dose. Call your medical practitioner about side effects. You may report side effects by calling (866) 280-5961.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
🧬 Mechanism of Action ▾
MECHANISM OF ACTION: Vitamin B 12 [ TREATMENT ]; FOLATE [ PREVENTION ]; OTHER [ SUPPLEMENTATION ];
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL .
📦 Storage and Handling ▾
STORAGE: Store at 20°-25°C (68°-77°F). Protect from light and moisture.
🧪 Inactive Ingredients ▾
FUNCTIONAL EXCIPIENTS: 25 mg ascorbates 3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), flavin adenine dinucleotide 6 (FAD), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride 6 (NADH), at least 23.33 mg phospholipid-omega 3 complex 5 [marine lipids], 25 mcg pyridoxal 5’ phosphate 6 (P5P), 25 mcg thiamine pyrophosphate 6 . OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], piperine [bioavailability enhancer], purified water, ubidecarenone [antioxidant], yellow beeswax.
1 The form most found in mammalian liver. 2 Pure amino acid, cysteinated iron chelate. 3 20% Daily Value (DV) of VITAMIN C, and 5% DV IRON for pregnancy.
4 NOT a significant source of magnesium and zinc. 5 Contains at least 12 mg phosphatidylserine (PS) – of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca). 6 Contains less than 2% (<25 mcg/each) of vitamins B 1 , B 2 , B 3 , and B 6 .
📋 Description ▾
DESCRIPTION: EnBrace HR® is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and direct monitoring of a licensed medical practitioner. EnBrace HR® contains a small amount of iron and may be taken concurrently with iron supplementation. INGREDIENTS: Folic acid, DHF+ (B 9 -Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg Folinic acid (B 9 -vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4.25 mg DFE) 2.5 mg Levomefolic acid (B 9 & B 12 - cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg Vitamin B 12 [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg 1 FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg 2,3
⚠️ Precautions ▾
PRECAUTIONS : GENERAL: 0.1 mg or more of folic acid daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. The safe tolerable limit for folic acid (in preparations) is 1 mg [emphasis added]. Folic acid is not a substitute for vitamin B 12 - although it may improve vitamin B 12 -deficient megaloblastic anemia.
Exclusive use of folic acid in treating vitamin B 12 -deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Specifically, vitamin B 12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when folate therapy is used as the only hematopoietic agent. Doses of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency.
Indiscriminate administration may mask the true diagnosis. A dietary deficiency of only vitamin B 12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.
DRUG INTERACTIONS: Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B 12 . CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: There is no evidence from long-term use in patients with pernicious anemia that vitamin B 12 or folate is carcinogenic. Pernicious anemia is associated with increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with vitamin B 12 .
PREGNANCY, NURSING MOTHERS, PEDIATRIC USE: Vitamin B 9 and vitamin B 12 are essential vitamins and requirements are increased during pregnancy. Amounts of vitamin B 9 and vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science - National Research Council for lactating women should be consumed during pregnancy. Vitamin B 12 and vitamin B 9 appear in the milk of nursing mothers in concentrations which approximate the mother’s vitamin B 12 and vitamin B 9 blood level.
Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academies of Science - National Research Council for lactating women should be consumed during lactation. Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Academy of Science - National Research Council.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL: EnBrace HR ® with DeltaFolate TM NDC 64661- 650 -30 Rx Only [15 mg DFE Folate] [50 mcg CBI][1.5 MG FeGC] ANTI-ANEMIA PREPARATION Low-IRON JayMac Pharmaceuticals, LLC SOFTGEL (30 ct BOTTLE) Prescription Prenatal Vitamin For Therapeutic Use image description
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |