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Folartex Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet, 30-count — NDC 85477-0511-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Folartex Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet, 30-count — NDC 85477-511-30 (Billing 85477-0511-30)

by Oncora Pharma, LLC · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Folartex Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet from Oncora Pharma, LLC, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 85477-0511-30
🏷️ FDA NDC (as labeled) 85477-511-30 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 85477-511-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
85477 labeler · 511 product · 30 package
Package marketed since
Feb 23, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 8547751130 4
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85477-511-30
Product NDC 85477-511
11-digit billing NDC 85477051130
NCPDP billing unit EA — each (per item)
UNII 01YAE03M7J, PQ6CK8PD0R, 1C6V77QF41, WR1WPI7EW8, 68Y4CF58BV, 6SO6U10H04 +6 more
SPL Set ID 0a4cb0ab-565f-45e8-a989-740bccef21cd
Established class (EPC) Vitamin C; Vitamin D; Vitamin B12
Chemical class Ascorbic Acid; Vitamin D; Vitamin B 12
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-23
Route ORAL
Dosage form TABLET
Substance BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; MAGNESIUM OXIDE; FERROUS BISGLYCINATE; POTASSIUM IODIDE

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

GPI-14 78310000000300
Quick answers
  • GPI-14 (Medi-Span): 78310000000300
Why two NDCs? The FDA registers this code as 85477-511-30 — 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 → 85477-0511-30. 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?

Folartex is an oral tablet multivitamin containing vitamins, minerals, and supplements. It includes vitamin C for antioxidant support, vitamins D and B12 for bone health and nerve function, B vitamins like biotin and pyridoxine typically used for energy and metabolism, calcium and magnesium for bone strength, iron for oxygen transport, and iodine for thyroid function. 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
85477-0511-30 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2026-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Folartex 300 ug/1; 60 mg/1; 10 ug/1; 4.5 mg/1; 26 mg/1; .28 mg/1; 1.67 mg/1; .013 mg/1; 80 mgthis 85477-0511-30 Oncora 30 tablets — — FDA listed —
Folyra 300 ug/1; 60 mg/1; 10 ug/1; 4.5 mg/1; 26 mg/1; .28 mg/1; 1.67 mg/1; .013 mg/1; 80 mg 85477-0523-30 Oncora 30 tablets — — FDA listed —
Folaten 300 ug/1; 60 mg/1; 10 ug/1; 4.5 mg/1; 26 mg/1; .28 mg/1; 1.67 mg/1; .013 mg/1; 80 mg 85477-0901-30 Oncora 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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

LabelerOncora Pharma, LLC
Labeler code85477
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Oncora Pharma, LLC labeler code 85477

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 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

INDICATIONS AND USAGE Folarex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.

⏱️ Dosage and Administration 12 words ▾

DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Folarex is contraindicated in patients with a known hypersensitivity to any of the ingredients.

⚠️ Warnings 42 words ▾

WARNINGS WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN . In the case of accidental overdose, ca l a doctor or poison control center immediately.

🤒 Adverse Reactions 48 words ▾

ADVERSE REACTIONS Al l ergic sensitization has been reported fo l owing both oral and parenteral administration of folic acid. You should ca l your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821.

📦 How Supplied / Storage and Handling 11 words ▾

HOW SUPPLIED Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.

📦 Storage and Handling 55 words ▾

STORAGE STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP contro l ed Room Temperature} Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do not use if seal is broken or missing. MADE IN USA Distributed by: 888-321-2821 Oncora Pharma Da l as, TX 75161

📋 Description 141 words ▾

DESCRIPTION Folarex is a prescription multivitamin/multimineral dietary supplement. SUPPLEMENT FACTS Servingsize Amount per serving: 1tablet % Daily Value Vitamin A (as Beta-Carotene) 300 mcg RAE 33% Vitamin C (as Ascorbic Acid) 60mg 67% Vitamin D (as Cholecalciferol) 10mcg 50% Vitamin E (as di-Alpha Tocopherol Acetate) 4.5 mg (10 IU) 33% Vitamin 86 (as Pyrldoxine HCI) 26mg 1529% Biotin 0.280mg 933% Folate 1.67 mg DFE 418% (from Folic Acid) 0.67 mg DFE (from 5 Methyl Tetrahydrotolate Calcium Salt) 1 mg DFE Vitamin 812 (as Cyanocobalamin) 0.013 mg 542% Calcium (as Calcium Carbonate) 80 mg 6% Magnesium (as Magnesium Oxide) 25mg 6% Ferrochel"" 20mg 111mg Iodine (as Potassium Iodide) 0.150mg 100% Other Ingredients: Microcrysta l ine Ce l ulose, Maltodextrin, Croscarme l ose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce l ulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1

⚠️ Precautions 44 words ▾

PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

📄 Package Label / Principal Display Panel 16 words ▾

PRINCIPAL DISPLAY PANEL 85477-511-30 Folarex MULTIVITAMIN 30 TABLETS Oncora Pharma, LLC 85477-511-30 Folarex MULTIVITAMIN 30 TABLETS

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

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 Folartex (this brand).

Top reported reactions

Fatigue3,676
Nausea3,234
Diarrhoea2,812
Headache2,601
Dizziness2,297
Dyspnoea2,044
Pain1,921

Age at onset

Neonate4
Infant15
Child51
Adolescent38
Adult1,012
Elderly1,025

Reporter sex

49,475 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization11,683
Life-threatening1,167
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 180 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.

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 Oncora Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oncora Pharma, 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.
← 85477-0503-30 · Oncora 85477-0513-30 · Oncora →
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.