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Accentrate PNV Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule Kit — NDC 70868-0510-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Accentrate PNV Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule Kit — NDC 70868-510-30 (Billing 70868-0510-30)

by Key Therapeutics · 1 KIT in 1 CARTON * 60 CAPSULE in 1 BOTTLE * 90 CAPSULE in 1 BOTTLE * 30 TABLET in 1 BOTTLE

This is a package of Accentrate PNV Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule Kit from Key Therapeutics, marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.

NDC 70868-0510-30
🏷️ FDA NDC (as labeled) 70868-510-30 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70868-510-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70868 labeler · 510 product · 30 package
Package marketed since
Feb 25, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7086851030 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70868-510-30
Product NDC 70868-510
11-digit billing NDC 70868051030
SPL Set ID 3008e7e0-01d9-bc7c-e063-6394a90a5247
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-17
Route ORAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 70868-510-30 — 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 → 70868-0510-30. 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.

Clinical

🧪 What is this product?

This is a prescription oral kit containing a prenatal multivitamin tablet and combination omega-3 softgel and mineral capsule. The multivitamin component typically supplies vitamins and minerals commonly given during pregnancy to support fetal development and maternal health. The omega-3 softgel provides fatty acids that are typically used to support heart and brain health. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
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.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70868-0510-30 You're viewing this Main listing 1 KIT in 1 CARTON * 60 CAPSULE in 1 BOTTLE * 90 CAPSULE in 1 BOTTLE * 30 TABLET in 1 BOTTLE 2025-02-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Accentrate PNVthis 70868-0510-30 Key 30 tablets — — FDA listed —
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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white / red
ShapeCapsule
Imprint110
Size2 mm
ScoringNot scored
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerKey Therapeutics
Labeler code70868
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Key Therapeutics labeler code 70868

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 40 words ▾

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately .

🎯 Indications and Usage 52 words ▾

INDICATIONS AND USAGE Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is a Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule indicated for preventing neural tube defects and use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The usual adult dose may be taken as one (1) white vitamin tablet (Neuro 110™), two (2) red omega-3 softgels (Omega 110™), and three (3) white mineral capsules (Minerals 110™) daily, before, during and after pregnancy, or as directed by a physician. FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate.

It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body, and supplies the active folate substrate, THF (tetrahydrofolate) for use in transformylation and methylation biochemistry.

Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). viii, ix,x NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. xi,xii During the first four weeks of pregnancy – when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. Folate is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia.

Folate is associated with methylation and transformylation biochemistry. Folate is involved in transformylation and methylation metabolism as well as, indirectly, succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division.

IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate. Other ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate.

4,5 L-methylfolate supplementation increases the formation of endothelian nitric oxide synthase resulting in increase nitric oxide. This causes vasodilation to the nerves, increasing blood supply to the nerves, and reducing vascular oxidative stress. xiv L-methylfolate supplementation also increases nitric oxide levels by increasing the amount of tetrahydrobioterin (BH4). BH4 is required for nitric oxide synthesis. xv FOLATE COENZYMES, COFACTORS, AND COMETABOLITES - The following ingredients are added to enhance the bioavailable potential of folate, and include: COBALAMIN - Methylcobalamin is required for two important reactions: the conversion of methylmalonyl CoA to succinyl CoA, a Krebs cycle intermediate, and the conversion of homocysteine to methionine, a reaction in which the methyl group of L-methylfolate is donated to remethylate homocysteine.

Homocysteine has been found to stimulate or alter transcription factors involved in inflammation, with an important ancillary consequence of BH 4 depletion. For example, it has been reported that homocysteine-mediated activation of sterol regulatory element binding protein (SREBP) upregulates expression of 3-hydroxy-3-methyl-glutaryl-coenzyme (HMG-CoA reductase) with increased biosynthesis and cellular uptake of cholesterol, the depletion of BH 4 being a secondary effect. PYRIDOXAL-5’-PHOSPHATE (PLP) is the active form of vitamin B.

The amino acid decarboxylase considered to decarboxylate both dihydroxyphenylalanine (DOPA) and 5-hydroxytryptophan (5-HTP) requires pyridoxal phosphate as coenzyme. Deficient le… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 84 words ▾

CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the articles contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

⚠️ Warnings and Cautions 193 words ▾

WARNINGS/PRECAUTIONS: Caution is recommended in patients with a family history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold.

Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress. Daily ingestion of more than 3 grams per day of omega-3 fatty acids (DHA, ALA, and EPA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants.

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

🤒 Adverse Reactions 88 words ▾

ADVERSE REACTIONS Allergic reactions have been reported following the use of oral and parenteral folate. xxix Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body have been associated with methylcobalamin. xxx Allergic reactions, acne, skin reactions, photosensitivity, nausea, vomiting, abdominal pain, loss of appetite, paresthesia, somnolence, nausea, and headaches have been associated with pyridoxal-5’-phosphate. xxxi Call your medical practitioner about side effects.

You may report side effects to the FDA at 1-800- FDA-1088 or call Key Therapeutics, LLC. at 888-981-8337.

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS Talk to your licensed medical practitioner, healthcare practitioner, personal physician, and/or pharmacist before taking or using any prescription, over-the-counter medicines, or herbal/health supplements alongside this product. Drugs which may interact with folate include: • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. • Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur.

Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. • Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. • NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. • Pancreatic Enzymes: Reduced serum folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase. • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine. • Smoking and Alcohol: Reduced serum folate levels have been noted. • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.

Metformin treatment in patients with type 2 diabetes decreases serum folate. • Warfarin can produce significant impairment in folate status after a 6-month therapy. Caution should be exercised with the concomitant use of folinic acid and trimethoprim- sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo-controlled study. Drugs which may interact with vitamin B 12 (Methylcobalamin): • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B 12 . • Nitrous oxide can produce a functional vitamin B 12 deficiency *These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure, or prevent any disease.

🤰 Pregnancy ~1 min read ▾

PREGNANCY AND NURSING MOTHERS Accentrate® PNV is intended for women of childbearing age who are – or desire to become, pregnant regardless of lactation status. Accentrate® PNV may be preferred for women at risk of dysregulated dopamine or serotonin regulation, which may include depression as a result of folate or cobalamin deficiency as well as folate-induced postpartum depression, or are at risk of folate-induced birth defects such as may be found with spina bifida and other neural tube defects (NTDs). It has been shown that folate enhances the synthesis and/or regeneration of tetrahydrobiopterin (BH 4 ), which is an essential cofactor in the biosynthesis of monoamine neurotransmitters serotonin, dopamine and norepinephrine i, ii, iii .

The conversion of tryptophan to serotonin also requires BH 4 . Accentrate® PNV may also be an appropriate source of folate for those at high risk of NTDs because of the amount and bioavailability of L-methylfolate contained therein. Accentrate® PNV is Pregnancy Category A; however, Accentrate® PNV is NOT a standard complete prenatal/postnatal supplement for the following reasons: Accentrate® PNV contains over 1,000% of DV of folate for pregnant and lactating women, which may or may not be important depending upon your genetic disposition and previous pregnancies; please consult with your licensed medical practitioner on advanced folate supplementation during pregnancy for women at risk of NTDs and/or suboptimal folate/depression/postpartum.

Accentrate® PNV contains over 600% of DV for cobalamin for pregnant and lactating women. Accentrate® PNV contains less than have the DV–only 37%–of iron for pregnant and lactating women, and Accentrate® PNV does not contain other vitamins and minerals that might be more suitable to your specific metabolic needs or part of a standard prenatal/postnatal multivitamin/multimineral/dietary supplement. iv, v, vi, vii

📦 How Supplied / Storage and Handling 158 words ▾

HOW SUPPLIED Accentrate® PNV (Folate/Omega/Iron) (6 mg-210 mg-10 mg) is available in a carton with NDC † 70868-510-30 containing: Neuro 110™ in a bottle with 30 (white) tablets with the imprint “110”, Omega 110™ in a bottle with 60 (red) softgels, and Minerals 110™ in a bottle with 90 (white) capsules. † This product is a prescription folate with or without other dietary ingredients, due to increased folate levels (AUG 2 1973 FR 20750). The “Rx” on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B 12 deficiency (pernicious anemia).

Based on the risk of obscuring pernicious anemia, this product requires supervision of a licensed medical practitioner. The “Rx Only” status and a National Drug Code (NDC), or similar Product Code, facilitate pedigree reporting requirements and supply-chain control as well as, in some cases, insurance-reimbursement applications.

📦 Storage and Handling 31 words ▾

Store in a dry place at 71°F or below. [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

📋 Description 207 words ▾

DESCRIPTION Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is an orally administered Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule. Accentrate® PNV contains a prenatal tablet, omega-3 softgels, and mineral capsules. Each one tablet contains 6 mg of L-methylfolate Calcium, each two softgel serving contains 210 mg of EPA and DHA, and each three capsule serving contain 10 mg of iron.

Each prenatal tablet contains: L-methylfolate Calcium 6 mg Pyridoxal-5-phosphate (Vitamin B6) 10 mg Methylcobalamin (Vitamin B12) 1 mg Riboflavin-5-phosphate (Vitamin B2) 3 mg Niacinamide (Vitamin B3) 5 mg Pantothenate (Vitamin B5) 15 mg Thiamine (Vitamin B1) 1 mg Vitamin D3 1200 IU / 30 mcg Vitamin C 85 mg Tyrosine 150 mg Other Ingredients: L-Glutathione, Starch, Croscarmellose Sodium, Silicon Dioxide, USP, Magnesium Stearate, Microcrystalline Cellulose. Each two omega-3 softgel serving contains: LYSOVETA® LPC which contains 1000 mg Lysophosphatidylcholine (LPC) 260 mg Eicosapentaenoic Acid 140 mg Docosahexaenoic Acid 70 mg Other Ingredients: Lysophosphatidylcholine (LPC)-Rich Oil, Extract of Antarctic Krill (Euphausia superba), Gelatin (bovine), Glycerin, Sorbitol, Water.

CONTAINS: Shellfish (Krill) Each three mineral capsule serving contains: Magnesium (magnesium glycinate chelate) 290 mg Zinc (zinc glycinate chelate) 35 mg Iron (ferrous bisglycinate chelate) 10 mg Other Ingredients: Potato starch, ascorbic acid, magnesium stearate, fumed silica, hypomellose, copper bisglycinate.

📚 References ~2 min read ▾

REFERENCES i Miller AL. “The methylation, neurotransmitter, and antioxidant connections between folate and depression.” Altern Med Rev. 2008 Sep;13(3):216-26. ii Bottiglieri T, et al. “Homocysteine, folate, methylation, and monoamine metabolism in depression.” J Neurol Neurosurg Psychiatry. 2000 Aug; 69(2):228-32. iii Young SN. “Folate and depression a – neglected problem.” J Psychiatry Neurosci 2007 March; 32(2):80-82. iv Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No.

99P3029). November 28, 2000. v Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H).

October 10, 2000. vi Hendler SS, Rorvik D, eds. PDR for Nutritional Supplements. Montvale, NJ: Thomson Healthcare; 2001. vii Hendler SS, Rorvik D.

PDR for Nutritional Supplements. 2nd ed. Montvale, NJ.

Physicians’ Desk Reference Inc; 2008. viii Hendler SS, Rorvik D, eds. PDR for Nutritional Supplements. Montvale, NJ: Thomson Healthcare; 2001.

10. ix Hendler SS, Rorvik D. PDR for Nutritional Supplements. 2nd ed.

Montvale, NJ. Physicians’ Desk Reference Inc; 2008. 11. x Bendich A, “Preventive Nutrition: The Comprehensive Guide for Health Professionals.” 2009.

Dietary Supplement Facts Regulations at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm. xi Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects. October 10, 2000. xii Veves A. et al. Diabetes 1998.

47:457-463 xiii Verhaar, MC. Atherosclerosis, Thrombosis, Vascular Biology, 2001. xv Federal Register Notice of April 9, 1971 (36 FR 6843). xvi Federal Register Notice of August 2, 1973 (38 FR 20750). xvii Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease. November 28, 2000. xvii Zhang G, et al. “Thiamine nutritional status and depressive symptoms are inversely associated among older Chinese adults.” J Nutr.

2013 Jan;143(1):53-8. xviii Naghashpour M, et al. “Riboflavin status and its association with serum hs-CRP levels among clinical nurses with depression.” J Am Coll Nutr. 2011 Oct;30(5):340-7. xix Nguyen, L., et al. “Mfsd2a is a transporter for the essential omega-3 fatty acid DHA in the brain.” Nature, 509 (2014). (7501), 503–506. xx Sugasini, D. “Enrichment of brain docosahexaenoic acid (DHA) is highly dependent upon the molecular carrier of dietary DHA: lysophosphatidylcholine is more efficient than either phosphatidylcholine or triacylglycerol.” J Nutr Biochem.

2019 Dec; 74:108231. xxi Ferchaud-Roucher, V, et al. "A potential role for lysophosphatidylcholine in the delivery of long chain polyunsaturated fatty acids to the fetal circulation." Biochimica et Biophysica Acta (BBA)-Molecular and Cell Biology of Lipids 1864.3 (2019): 394-402. xxii Hermans, E, et al. “Dietary LPC-Bound n-3 LCPUFA Protects against Neonatal Brain Injury in Mice but Does Not Enhance Stem Cell Therapy.” Nutrients 16.14 (2024): 2252. xxiii Federal Register Notice of April 9, 1971 (36 FR 6843). xxiv Federal Register Notice of August 2, 1973 (38 FR 20750). xxv Federal Register Notice of October 17, 1980 (45 FR 69043 at 69044). xxvi Federal Register Notice of March 5, 1996 (61 FR 8760). xxvii Federal Register Notice of August 2, 1973 (38 FR 20750). xxviii Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No.

99P3029). November 28, 2000. xxix Natural Standard Research Collaboration (NIH). Folate (folic acid) Monograph 2009. xxx Natural Standard Research Collaboration (NIH).

Vitamin B12 Monograph 2009. xxxi Alternative Medicine Review Vitamin B6 Monograph Volume 6, Number 1, 2001.

📄 Package Label / Principal Display Panel 1 words ▾

label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

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.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Key Therapeutics. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Key Therapeutics 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.
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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.