Therapeutic class — broad (HIC1)Electrolyte Balance/Metabolism/Nutrition
HIC2 codeC6
Therapeutic class — intermediate (HIC2)Vitamins
HIC3 codeC6Z
Therapeutic class — specific (HIC3)Multivitamin Preparations
AHFS code20:04.04.00
AHFS classIron Preparations
FDB label nameENBRACE HR SOFTGEL
FDB brand nameEnbrace Hr
Legend statusQ — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs?
The FDA registers this code as 64661-650-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64661-0650-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name ENBRACE HR SOFTGELIngredient Multivit41/Iron/Folate8/Ps-Dha
🧪 What is this product?
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.
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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.
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.
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.
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.
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.
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.
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.
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.
The official label also statesFUNCTIONAL 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. CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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
$4.478
$134.35 / 30 capsules
Medicaid paysCMS SDUD · 12 mo
$4.63
$139.02 / 30 capsules
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 3% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64661-0650-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11.4K
Units reimbursed last 4 qtrs
341.9K
Gross reimbursed last 4 qtrs
$1.58M
Avg / prescription
$138.83
Avg / unit
$4.6339
Latest quarter Q4 2025
2.6KRx
Medicaid pays / ea
$4.6339
gross reimbursed
vs
NADAC / ea
$4.4782
acquisition cost
=
Spread
+$0.1557
+3% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
95% MCO
Fee-for-service · 543 Rx Managed care · 10,869 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.67,050
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Louisiana7,050 /100k
2Alaska282 /100k
3North Carolina55.7 /100k
4Oklahoma55.5 /100k
5New York38.6 /100k
6Arkansas26.4 /100k
7Pennsylvania5.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Enbrace Hr — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Enbrace Hr. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$23.1K
Claims incl. refills
132
Beneficiaries
93
Spend / beneficiary
$247.88
Spend / claim
$174.64
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
📦 Packaging — all sizes for this product
Package NDC
Description
Marketing start
Status
64661-0650-30 You're viewing this
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (64661-650-30)
2011-08-12
Active
🧭 About this NDC listing & data coverage
Finished prescription productMarketed without an FDA application
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 NDCApplies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk
— Not published for this NDCMost self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)
✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 64661-650-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64661-0650-30, written without dashes as 64661065030. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64661-0650-30, the first segment (64661) is the labeler code FDA assigned to Jaymac Pharmaceuticals, LLC; the middle segment (0650) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Jaymac Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jaymac Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
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 Administration71 words▾
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 Reactions39 words▾
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 Action17 words▾
MECHANISM OF ACTION: Vitamin B 12 [ TREATMENT ]; FOLATE [ PREVENTION ]; OTHER [ SUPPLEMENTATION ];
📦How Supplied / Storage and Handling10 words▾
HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL .
📦Storage and Handling10 words▾
STORAGE: Store at 20°-25°C (68°-77°F). Protect from light and moisture.
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~1 min read▾
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). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
