Home › NDC Lookup › Ingredients › Folate, Vitamin D3 › 59088-0301-54
Folixate Folate, Vitamin D3 1000 ug; 125 ug Tablet, 30-count — NDC 59088-0301-54 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Folixate Folate, Vitamin D3 1000 ug; 125 ug Tablet, 30-count — NDC 59088-301-54 (Billing 59088-0301-54)

by PureTek Corporation · 30 TABLET in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Folixate Folate, Vitamin D3 1000 ug; 125 ug Tablet from PureTek Corporation, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.

NDC 59088-0301-54
🏷️ FDA NDC (as labeled) 59088-301-54 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 59088-301-54 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59088 labeler · 301 product · 54 package
Package marketed since
Dec 5, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC)
0359088301548
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-301-54
Product NDC 59088-301
11-digit billing NDC 59088030154
NCPDP billing unit EA — each (per item)
RxCUI 2671090, 2671097
UNII A9R10K3F2F, 9VU1KI44GP
UPC 0359088301548
SPL Set ID 0bb91f61-b61b-c894-e063-6394a90ae51c
Established class (EPC) Folate Analog; Vitamin D
Chemical class Folic Acid; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-05
Route ORAL
Dosage form TABLET
Substance LEVOMEFOLATE CALCIUM; VITAMIN D

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 82991502400330
GCN Seq No 086007
GCN 55626
HICL code 047514
Ingredient (HICL) Vitamin D3/Levomefolate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6D
Therapeutic class — specific (HIC3) Vitamin D Preparations
AHFS code 88:16.00.00
AHFS class Vitamin D
FDB label name DERMACINRX FOLIXATE TABLET
FDB brand name Dermacinrx Folixate
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 086007
  • GCN: 55626
  • GPI-14 (Medi-Span): 82991502400330
  • HICL (First Databank): 047514
  • AHFS class code: 88:16.00.00
  • RxCUI (RxNorm): 2671090
Why two NDCs? The FDA registers this code as 59088-301-54 — 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 → 59088-0301-54. 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.

RxNorm drug class

This medicine belongs to the Folate Analog class.

Pharmacologic class Folate Analog
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DERMACINRX FOLIXATE TABLET Ingredient Vitamin D3/Levomefolate
🧪 What is this product?

Folixate is an oral tablet containing levomefolate calcium and vitamin D3. Levomefolate calcium is a form of folate, a B vitamin typically used to support normal cell division and DNA formation. Vitamin D3 is commonly used to support bone health and calcium absorption. 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
59088-0301-54 You're viewing this Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2023-12-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folixate 1000 ug/1; 125 ugthis 59088-0301-54 PureTek 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerPureTek Corporation
Labeler code59088
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

INDICATIONS AND USAGE Folixate ™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate level and Vitamin D supplementation. Folixate™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.

⏱️ Dosage and Administration 15 words ▾

DOSAGE AND ADMINISTRATION Take one tablet daily or as directed by a licensed healthcare practitioner.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folixate ™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin D, and hypervitaminosis D.

⚠️ Warnings and Cautions 74 words ▾

WARNINGS AND PRECAUTIONS Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.

Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

🤒 Adverse Reactions 42 words ▾

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folate. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.

🧬 Clinical Pharmacology 147 words ▾

CLINICAL PHARMACOLOGY The in vivo synthesis of the major biologically active metabolites of Vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization.

Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules. There is a time lag of 10 to 24 hours between the administration of Vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

📦 How Supplied / Storage and Handling 161 words ▾

HOW SUPPLIED Folixate ™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-301-54). * This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2, 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed healthcare practitioner supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision.

There are no implied or explicit claims on therapeutic equivalence.

📦 Storage and Handling 43 words ▾

STORAGE KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from heat, light and moisture. Tamper Evident: Do not use if seal is broken or missing.

📋 Description 86 words ▾

DESCRIPTION Folixate ™ is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate level and Vitamin D supplementation due to Vitamin D deficiency. Folixate ™ should be administered under the supervision of a licensed healthcare practitioner. Each tablet contains: Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg of L-5-methylfolate) Vitamin D3 (as Cholecalciferol)………....................125 mcg (5000 IU) Each tablet contains the following inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, Vegetable Stearic Acid.

📄 Package Label / Principal Display Panel 2 words ▾

Folixate™ 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

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) — 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
← 59088-0299-08 · PureTek 59088-0304-03 · PureTek →
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.