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Folcyteine Multivitamin 47 mg; 800 [iU]/1; 1000 ug; 200 mg; 16 mg Tablet, 30-count — NDC 59088-0795-54 package photo

Folcyteine Multivitamin 47 mg; 800 [iU]/1; 1000 ug; 200 mg; 16 mg Tablet, 30-count

by PureTek Corporation · 30 TABLET in 1 BOTTLE, PLASTIC (59088-795-54)
NDC 59088-0795-54
🏷️ FDA NDC (as labeled) 59088-795-54 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 59088-795-54
Product NDC 59088-795
11-digit billing NDC 59088079554
NCPDP billing unit EA — each (per item)
UNII MLM29U2X85, 1C6V77QF41, 935E97BOY8, WYQ7N0BPYC, RHO26O1T9V
UPC 0359088795545
SPL Set ID 04cf0026-e29b-ffd5-e063-6294a90aca1f
Established class (EPC) Vitamin D; Antidote; Antidote for Acetaminophen Overdose; Mucolytic
Mechanism of action Reduction Activity
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Glutathione Concentration
Chemical class Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-14
Route ORAL
Dosage form TABLET
Substance CALCIUM CITRATE; CHOLECALCIFEROL; FOLIC ACID; ACETYLCYSTEINE; MAGNESIUM CITRATE
GPI-14 78200000000300
GCN Seq No 085352
GCN 54811
HICL code 045858
Ingredient (HICL) Folic/Calcium/D3/Mg Cit/A-Cyst
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6M
Therapeutic class — specific (HIC3) Folic Acid Preparations
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name FOLCYTEINE CAPLET
FDB brand name Folcyteine
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 59088-795-54 — 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 → 59088-0795-54. 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.

🏭 Manufacturer & labeler

LabelerPureTek Corporation
Labeler code59088
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio178 products on file
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 FOLCYTEINE CAPLET Ingredient Folic/Calcium/D3/Mg Cit/A-Cyst
🧪 What is this product?

Folcyteine is an oral tablet containing acetylcysteine, calcium citrate, cholecalciferol (vitamin D), folic acid, and magnesium citrate. Acetylcysteine is commonly used as a mucolytic agent and as an antidote in acetaminophen overdose. Calcium citrate and magnesium citrate are mineral supplements typically used to support bone health and normal body functions. Folic acid and cholecalciferol (vitamin D) are vitamins typically used to support general nutritional needs. 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.

💊 What it looks like

Color yellow
ShapeCapsule
Size22 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

7 inactive ingredients listed in the exact product block matched to this NDC.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folcyteine 47 mg/1; 800 [iU]/1; 1000 ug/1; 200 mg/1; 16 mgthis 59088-0795-54 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
Sep 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Folcyteine (this brand).

Top reported reactions

Fatigue3,676
Nausea3,235
Diarrhoea2,815
Headache2,599
Dizziness2,294
Dyspnoea2,042
Pain1,922

Age at onset

Neonate4
Infant15
Child51
Adolescent38
Adult1,012
Elderly1,025

Reporter sex

49,471 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Death2,304
Disabling2,010
Life-threatening1,167
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,373 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0795-54 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (59088-795-54) 2023-09-14 Active

🧭 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) ✓ 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 FDA registers it as 59088-795-54, 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: 59088-0795-54, written without dashes as 59088079554. 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 59088-0795-54, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0795) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) 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 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.

📄 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 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 48 words ▾

Indications and Usage : Folcyteine™ is indicated as a vitamin, mineral supplementation for adult men and women. Folic acid is used to treat megaloblastic anemia caused by folic acid deficiency, including cases associated with tropical or nontropical sprue, as well as anemia due to nutritional deficiency or pregnancy.

⏱️ Dosage and Administration 25 words ▾

Dosage and Administration : One (1) Folcyteine™ caplet daily or as directed by a physician. Do not administer to children under the age of 12.

⛔ Contraindications 38 words ▾

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

⚠️ Warnings 48 words ▾

Warnings : Patients with kidney disease or thyroid disease should consult a physician or healthcare provider before using this product. Use during pregnancy or breast-feeding only as directed. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias caused by vitamin B12 deficiency.

🤒 Adverse Reactions 32 words ▾

Adverse Reactions : Allergic sensitization has been reported following both oral and parenteral administration of folic acid. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📦 How Supplied / Storage and Handling 33 words ▾

How Supplied : Folcyteine™ are pale yellow, clear film-coated caplets in bottles containing 30 caplets – NDC 59088-795-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

📦 Storage and Handling 61 words ▾

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Avoid excessive heat. Do not use if the seal under bottle cap is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 1-877-921-7873

📋 Description 52 words ▾

Prescribing Information: Description : Folcyteine™ caplets are intended for oral administration. Active Ingredients : Each caplet contains : Vitamin D3 (as Cholecalciferol) .................. 20 mcg (800 IU) Folate (as Folic Acid)...1,667 mcg DFE (1,000 mcg Folic Acid) Calcium (as Calcium Citrate).......................................

47 mg Magnesium (as Magnesium Citrate)........................... 16 mg N-Acetyl-L-Cysteine................................................... 200 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0794-05 · Puretek 59088-0801-00 · 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.