Home › NDC Lookup › Ingredients › Monomethyl Fumarate › 69387-0001-01
Bafiertam monomethyl fumarate 95 mg Capsule, 120-count — NDC 69387-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bafiertam monomethyl fumarate 95 mg Capsule, 120-count — NDC 69387-001-01 (Billing 69387-0001-01)

by Banner Life Sciences LLC · 120 CAPSULE in 1 BOTTLE

This is a package of 120 capsules of Bafiertam monomethyl fumarate 95 mg Capsule from Banner Life Sciences LLC, marketed since Apr 2020 and currently FDA-listed. It is this product's only package size.

NDC 69387-0001-01
🏷️ FDA NDC (as labeled) 69387-001-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 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 69387-001-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69387 labeler · 001 product · 01 package
Package marketed since
Apr 28, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
120 EA per package
Barcode (UPC)
0369387001018
Medicaid fills, this package
135 prescriptions in the last four reported quarters
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69387-001-01
Product NDC 69387-001
11-digit billing NDC 69387000101
NCPDP billing unit EA — each (per item)
RxCUI 2393587, 2393593
UNII 45IUB1PX8R
UPC 0369387001018
Application # NDA210296
SPL Set ID a161f9d4-70f1-4097-957a-eafb35d3274f
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-28
Route ORAL
Dosage form CAPSULE
Substance MONOMETHYL FUMARATE

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

GCN Seq No 081120
GCN 48156
HICL code 046576
Ingredient (HICL) Monomethyl Fumarate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0E
Therapeutic class — specific (HIC3) Agents To Treat Multiple Sclerosis
AHFS code 90:04.08.00
AHFS class Fumarates
FDB label name BAFIERTAM DR 95 MG CAPSULE
FDB brand name Bafiertam
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081120
  • GCN: 48156
  • HICL (First Databank): 046576
  • AHFS class code: 90:04.08.00
  • RxCUI (RxNorm): 2393587
Why two NDCs? The FDA registers this code as 69387-001-01 — 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 → 69387-0001-01. 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 Other immunosuppressants class.

Drug family (ATC) Other immunosuppressants
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 BAFIERTAM DR 95 MG CAPSULE Ingredient Monomethyl Fumarate
📗 Our plain-language guide HelloPharmacist
  • Bafiertam helps manage relapsing forms of MS — meaning the type where symptoms flare up and then ease off, at least partly. It's approved for relapsing-remitting MS, clinically iso...
  • What exactly does Bafiertam do for my MS?
  • Flushing — sudden redness, warmth, or tingling in your face and skin — is actually one of the most common side effects, reported by a significant number of people on this class of...
  • I've heard flushing is a big problem. Will that happen to me, and is there anything I can do about it?
📖 Read our full Monomethyl Fumarate guide →

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 $57.97 $6,955.85 / 120 capsules
Medicare drug plans payPart D · Q2 2026 $60.86 $7,302.80 / 120 capsules
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
69387-0001-01 You're viewing this Main listing 120 CAPSULE in 1 BOTTLE 2020-04-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bafiertam 95 mgthis 69387-0001-01 Banner 120 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2020
First FDA approval
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 28, 2020 RLD RS ⏳ ~8.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11903918 — method of use (U-1384)
US 10918615 — method of use (U-1384)
US 10918616 — method of use (U-1384)
US 11590095 — method of use (U-1384)
US 9511043 — method of use (U-1384)
US 9326965 — method of use (U-1384)
US 9814692 — method of use (U-1384)
US 9636318 — method of use (U-1384)
US 9814691 — method of use (U-1384)
US 10105336 — method of use (U-1384)
US 9820961 — method of use (U-1384)
US 10098863 — method of use (U-1384)
US 9517209 — drug product
US 9566259 — drug product
US 9326947 — drug product
US 10105335 — drug product
US 10105337 — drug product
US 10918617 — drug product
US 9636319 — drug product
US 10945985 — drug product
US 9820960 — drug product
2020 2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (21)
PatentTypeUse codeExpires
US 11903918 ↗ Method of use U-1384 Feb 27, 2035
US 10918615 ↗ Method of use U-1384 Feb 27, 2035
US 10918616 ↗ Method of use U-1384 Feb 27, 2035
US 11590095 ↗ Method of use U-1384 Feb 27, 2035
US 9511043 ↗ Method of use U-1384 Feb 27, 2035
US 9326965 ↗ Method of use U-1384 Feb 27, 2035
US 9814692 ↗ Method of use U-1384 Feb 27, 2035
US 9636318 ↗ Method of use U-1384 Feb 27, 2035
US 9814691 ↗ Method of use U-1384 Feb 27, 2035
US 10105336 ↗ Method of use U-1384 Feb 27, 2035
US 9820961 ↗ Method of use U-1384 Feb 27, 2035
US 10098863 ↗ Method of use U-1384 Feb 27, 2035
US 9517209 ↗ Drug product — Feb 27, 2035
US 9566259 ↗ Drug product — Feb 27, 2035
US 9326947 ↗ Drug product — Feb 27, 2035
US 10105335 ↗ Drug product — Feb 27, 2035
US 10105337 ↗ Drug product — Feb 27, 2035
US 10918617 ↗ Drug product — Feb 27, 2035
US 9636319 ↗ Drug product — Feb 27, 2035
US 10945985 ↗ Drug product — Feb 27, 2035
US 9820960 ↗ Drug product — Feb 27, 2035
Common questions
Is there a generic version of BAFIERTAM DR 95 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BAFIERTAM DR 95 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🧪 Avoiding an ingredient? See Monomethyl Fumarate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII U72Q2I8C85
    A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

24 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.

Manufacturer & labeler

LabelerBanner Life Sciences LLC
Application holderBANNER LIFE SCIENCES LLC
FDA applicationNDA210296 (NDA)
Labeler code69387
First marketedApr 2020
Product typeHuman Prescription Drug
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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Blood tests are required prior to initiation of BAFIERTAM. ( 2.1 ) Starting dose: 95 mg twice a day, orally, for 7 days. ( 2.2 ) Maintenance dose after 7 days: 190 mg (administered as two 95 mg capsules) twice a day, orally. ( 2.2 ) Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix contents with food. ( 2.3 ) Take BAFIERTAM with or without food. ( 2.3 )

2.1Blood Tests Prior to Initiation of BAFIERTAM Obtain the following prior to treatment with BAFIERTAM: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] .

2.2Dosing Information The starting dosage for BAFIERTAM is 95 mg twice a day orally for 7 days. After 7 days, the dosage should be increased to the maintenance dosage of 190 mg (administered as two 95 mg capsules) twice a day orally. Temporary dosage reductions to 95 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage.

Within 4 weeks, the recommended dosage of 190 mg twice a day should be resumed. Discontinuation of BAFIERTAM should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to BAFIERTAM dosing, may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )] .

2.3Administration Instructions Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix the contents with food. BAFIERTAM can be taken with or without food.

2.4Blood Tests to Assess Safety After Initiation of BAFIERTAM Obtain a complete blood cell count (CBC), including lymphocyte count, 6 months after initiation of BAFIERTAM and then every 6 to 12 months thereafter, as clinically indicated [see Warnings and Precautions ( 5.3 )] . Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels during treatment with BAFIERTAM, as clinically indicated [see Warnings and Precautions ( 5.4 )] .

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS BAFIERTAM is available as soft gelatin delayed-release capsules containing 95 mg of monomethyl fumarate. The 95 mg capsule is white, opaque, oval, coated, and printed with “95” in black ink on the body. Delayed-release capsules: 95 mg ( 3 )

⛔ Contraindications 76 words ▾

4 CONTRAINDICATIONS BAFIERTAM is contraindicated in patients: with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Reactions may include anaphylaxis or angioedema. [see Warnings and Precautions ( 5.1 )]. taking dimethyl fumarate or diroximel fumarate [see Drug Interactions ( 7.1 )]. Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the excipients of BAFIERTAM.

Co-administration with dimethyl fumarate or diroximel fumarate. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema: Discontinue and do not restart BAFIERTAM if these occur. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold BAFIERTAM at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding BAFIERTAM in cases of serious infection until the infection has resolved.

( 5.3 ) Lymphopenia: Obtain a CBC including lymphocyte count before initiating BAFIERTAM, after 6 months, and every 6 to 12 months thereafter. Consider interruption of BAFIERTAM if lymphocyte counts <0.5 x 10 9 /L persist for more than six months. ( 5.4 ) Liver Injury: Obtain serum aminotransferase, alkaline phosphatase and total bilirubin levels before initiating BAFIERTAM and during treatment, as clinically indicated.

Discontinue BAFIERTAM if clinically significant liver injury induced by BAFIERTAM is suspected. ( 5.5 )

5.1Anaphylaxis and Angioedema BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

5.2Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial.

During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x10 9 /L for 3.5 years) while taking dimethyl fumarate [see Warnings and Precautions ( 5.4 )] . The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.

PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9x10 9 /L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8x10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold BAFIERTAM and perform an appropriate diagnostic evaluation.

Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory and orientation leading to confusion and personality changes. Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Cases of PML diagnosed based on MRI findings, and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with PML.

Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.1 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.2 ) ] Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions ( 5.3 ) ] Lymphopenia [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.5 )] Flushing [see Warnings and Precautions ( 5.6 )] Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence for dimethyl fumarate [the prodrug of BAFIERTAM] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Banner Life Sciences at toll-free phone: 1-866-MMF- 95MG or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules (the prodrug of BAFIERTAM). Adverse Reactions in Placebo-Controlled Trials with Dimethyl Fumarate In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies ( 14 )].

The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea. Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥ 2% Higher Incidence than Placebo Adverse Reaction Dimethyl Fumarate 240 mg Twice Daily N=769 (%) Placebo N=771 (%) Flushing 40 6 Abdominal pain 18 10 Diarrhea 14 11 Nausea 12 9 Vomiting 9 5 Pruritus 8 4 Rash 8 3 Albumin urine present 6 4 Erythema 5 1 Dyspepsia 5 3 Aspartate aminotransferase increased 4 2 Lymphopenia 2 <1 Gastrointestinal Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia).

In clinical trials, the incidence of GI events was higher early in the course of treatment (primarily during the first month) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of patients on placebo discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in clinical trial patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%).

Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate in clinical trials was seen primarily during the first six months of treatment, and most patients with elevations had levels < 3 times the upper limit of normal (ULN). Elevations of alanine aminotransferase and aspartate aminotransferase to ≥ 3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and in patients on placebo, and were balanced between the groups.

There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1%, and were similar in patients treated with dimethyl fumarate or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy with dimethyl fumarate.

Adverse Reactions in Studies with BAFIERTAM (Monomet… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 47 words ▾

7 DRUG INTERACTIONS

7.1Concomitant Dimethyl Fumarate or Diroximel Fumarate Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, BAFIERTAM is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate. BAFIERTAM may be initiated the day following discontinuation of either of these drugs.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary Available data from a pregnancy registry for dimethyl fumarate (the prodrug of BAFIERTAM), observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy ( see Data ). In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses ( see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data In a prospective observational pregnancy registry for dimethyl fumarate (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI: 1.9-6.1). No specific pattern of major birth defects was identified. Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.

Animal Data In rats administered DMF orally (0, 25, 100, and 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of MMF (380 mg/day).

In rabbits administered DMF orally (0, 25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD of MMF. Oral administration of DMF (0, 25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested.

Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD of MMF.

8.2Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BAFIERTAM and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Animal Toxicity Data Oral administration of monomethyl fumarate (MMF) (0, 40, 100, or 250 mg/kg/day) to juvenile rats from postnatal day 28 to 70 resulted in reduced body weight and bone growth, delayed sexual maturation in females, and renal tubular (exfoliated cells or degeneration) and gastrointestinal (nonglandular stomach hyperkeratosis or hyperplasia) effects at all but the lowest dose tested. No adverse effects were observed on neurobehavioral development.

8.5Geriatric Use Clinical studies of dimethyl fumarate (the prodrug of BAFIERTAM) and of BAFIERTAM did not incl… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from a pregnancy registry for dimethyl fumarate (the prodrug of BAFIERTAM), observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy ( see Data ). In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses ( see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data In a prospective observational pregnancy registry for dimethyl fumarate (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI: 1.9-6.1). No specific pattern of major birth defects was identified. Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.

Animal Data In rats administered DMF orally (0, 25, 100, and 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of MMF (380 mg/day).

In rabbits administered DMF orally (0, 25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD of MMF. Oral administration of DMF (0, 25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested.

Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD of MMF.

🧒 Pediatric Use 81 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Animal Toxicity Data Oral administration of monomethyl fumarate (MMF) (0, 40, 100, or 250 mg/kg/day) to juvenile rats from postnatal day 28 to 70 resulted in reduced body weight and bone growth, delayed sexual maturation in females, and renal tubular (exfoliated cells or degeneration) and gastrointestinal (nonglandular stomach hyperkeratosis or hyperplasia) effects at all but the lowest dose tested. No adverse effects were observed on neurobehavioral development.

🧓 Geriatric Use 35 words ▾

8.5Geriatric Use Clinical studies of dimethyl fumarate (the prodrug of BAFIERTAM) and of BAFIERTAM did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which monomethyl fumarate (MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF has been shown to activate the Nuclear factor (erythroid-derived 2) like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro .

12.2Pharmacodynamics Potential to prolong the QT interval In a placebo controlled thorough QT study performed in healthy subjects with dimethyl fumarate [the prodrug of BAFIERTAM], there was no evidence that dimethyl fumarate caused QT interval prolongation of clinical significance (i.e., the upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 ms).

12.3Pharmacokinetics Pharmacokinetics of monomethyl fumarate have previously been characterized after oral administration of its prodrug, dimethyl fumarate, as delayed-release capsules, in healthy subjects and subjects with multiple sclerosis. After oral administration, dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF). Additional pharmacokinetic data of monomethyl fumarate were obtained after oral administration of BAFIERTAM, the monomethyl fumarate delayed-release capsules, in healthy subjects.

Absorption Following oral administration of BAFIERTAM 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions, the median T max of MMF is 4.03 hours; and the peak plasma concentration (C max ) and overall exposure (AUC) of monomethyl fumarate are bioequivalent to those after oral administration of 240 mg dimethyl fumarate delayed-release capsule. A high-fat, high-calorie meal did not significantly affect the overall monomethyl fumarate plasma exposure (AUC), but decreased the C max of MMF by 20%, with prolonged absorption.

The median T max of MMF was delayed from approximately 4.0 hours to 11 hours by a high fat meal. Distribution From studies with dimethyl fumarate (the prodrug of BAFIERTAM), it is shown that the apparent volume of distribution of MMF varies between 53 and 73 L in healthy subjects. Human plasma protein binding of MMF is 27-45% and independent of concentration.

Elimination Metabolism In humans, metabolism of MMF occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP450) system. MMF, fumaric and citric acid, and glucose are the major metabolites of MMF in plasma. Excretion From studies with dimethyl fumarate (the prodrug of BAFIERTAM), exhalation of CO 2 is the primary route of elimination, accounting for approximately 60% of the dimethyl fumarate dose.

Renal and fecal elimination are minor routes of elimination for MMF, accounting for 16% and 1% of the dimethyl fumarate dose, respectively. Trace amounts of unchanged MMF were present in urine. The plasma half-life of MMF is approximately 0.5 hours and no circulating MMF is present at 24 hours in the majority of individuals following oral administration of BAFIERTAM 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions.

Accumulation of MMF does not occur with multiple doses of dimethyl fumarate. Specific Populations Body weight, gender, and age differences do not require dosage adjustment. No studies have been conducted in subjects with hepatic or renal impairment.

However, neither condition would be expected to affect plasma exposure to MMF and therefore, no dosage adjustment is necessary. Drug Interaction Studies No potential drug interactions with dimethyl fumarate or MMF were identified in in vitro CYP inhibition and induction studies, or in P-glycoprotein studies. Single doses of interferon beta-1a or glatiramer acetate did not alter the pharmacokinetics of MMF.

Aspirin, when administered approximately 30 minutes before di… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 69 words ▾

12.1Mechanism of Action The mechanism by which monomethyl fumarate (MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF has been shown to activate the Nuclear factor (erythroid-derived 2) like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro .

📦 How Supplied / Storage and Handling 195 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BAFIERTAM is available as soft gelatin delayed-release capsules containing 95 mg of monomethyl fumarate. The 95 mg capsules are white, opaque, oval, and coated with “95” printed in black ink on the body. BAFIERTAM is available as follows: 95 mg capsules: bottle of 120 capsules (NDC 69387-001-01).

16.2Storage and Handling Unopened Bottle Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Under these conditions, BAFIERTAM is stable until the expiration date indicated on the package.

Opened Bottle Opened bottles may be stored at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) permitted [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.

Under these conditions, BAFIERTAM is stable for 3 months. Capsules may become deformed if kept at high temperatures.

16.1How Supplied BAFIERTAM is available as soft gelatin delayed-release capsules containing 95 mg of monomethyl fumarate. The 95 mg capsules are white, opaque, oval, and coated with “95” printed in black ink on the body. BAFIERTAM is available as follows: 95 mg capsules: bottle of 120 capsules (NDC 69387-001-01).

📦 Storage and Handling 90 words ▾

16.2Storage and Handling Unopened Bottle Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Under these conditions, BAFIERTAM is stable until the expiration date indicated on the package.

Opened Bottle Opened bottles may be stored at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) permitted [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container.

Under these conditions, BAFIERTAM is stable for 3 months. Capsules may become deformed if kept at high temperatures.

📋 Description 172 words ▾

11 DESCRIPTION BAFIERTAM contains the active ingredient monomethyl fumarate, which is an unsaturated monomethyl ester. It is also known by its chemical name, fumaric acid monomethyl ester, (C 5 H 6 O 4 ). It has the following structure: Monomethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 130.10.

BAFIERTAM is provided as soft gelatin delayed-release capsules for oral administration, containing 95 mg of monomethyl fumarate consisting of the following inactive ingredients: Glyceryl caprylate/caprate, lactic acid, polyoxyl 40 hydrogenated castor oil and povidone K30. The capsule shell, printed with black ink, contains the following inactive ingredients: ammonium hydroxide, butyl alcohol, ferrosoferric oxide, isopropyl alcohol, gelatin, propylene glycol, shellac, solution of sorbitans and sorbitol and titanium dioxide.

The coating system includes the following inactive ingredients: colloidal anhydrous silica, GMCC Type 1 mono and di-glycerides, hypromellose type 2910, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol (MW=400), polyvinyl alcohol part hydrolyzed, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosage Inform patients that they will be provided one strength of BAFIERTAM when starting treatment: take one capsule for the 7 day starter dose and two capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow BAFIERTAM capsules whole and intact.

Inform patients to not crush, chew, or mix capsule contents with food. Inform patients that BAFIERTAM can be taken with or without food [see Dosage and Administration ( 2.2 , 2.3 )]. Anaphylaxis and Angioedema Advise patients to discontinue BAFIERTAM and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions ( 5.1 )].

Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received dimethyl fumarate (the prodrug of monomethyl fumarate). Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML.

Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions ( 5.2 )] . Herpes Zoster and Other Serious Opportunistic Infections Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received dimethyl fumarate.

Instruct the patient of the importance of contacting their healthcare provider if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions ( 5.3 )]. Lymphocyte Counts Inform patients that BAFIERTAM may decrease lymphocyte counts. A blood test should be obtained before they start therapy.

Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] . Liver Injury Inform patients that BAFIERTAM may cause liver injury. Instruct patients treated with BAFIERTAM to report promptly to their healthcare provider any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions ( 5.5 )] . Flushing Inform patients that flushing is one of the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing.

Advise patients experiencing flushing that taking a non-enteric coated aspirin prior to taking BAFIERTAM may help [see Adverse Reactions ( 6.1 )]. Gastrointestinal (GI) Reactions Inform patients that GI events (abdominal pain, diarrhea, and nausea) are some of the most common adverse reactions, especially at the initiation of therapy, and may decrease over time. Some patients may experience more severe GI events.

Advise patients to immediately contact their healthcare provider and discontinue BAFIERTAM if they experience gastrointestinal bleeding (e.g., rectal bleeding, bloody diarrhea, hematemesis) or other serious gastrointestinal adverse events (e.g., severe abdominal pain, severe vomiting and/or diarrhea) [see Warnings and Precautions ( 5.7 )] . Pregnancy Instruct patients that if they are pregnant or plan to become pregnant while taking BAFIERTAM, they should inform their healthcare provider [see Use in Specific Populations ( 8.1 )].

Manufa… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pharmacokinetics of monomethyl fumarate have previously been characterized after oral administration of its prodrug, dimethyl fumarate, as delayed-release capsules, in healthy subjects and subjects with multiple sclerosis. After oral administration, dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF). Additional pharmacokinetic data of monomethyl fumarate were obtained after oral administration of BAFIERTAM, the monomethyl fumarate delayed-release capsules, in healthy subjects.

Absorption Following oral administration of BAFIERTAM 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions, the median T max of MMF is 4.03 hours; and the peak plasma concentration (C max ) and overall exposure (AUC) of monomethyl fumarate are bioequivalent to those after oral administration of 240 mg dimethyl fumarate delayed-release capsule. A high-fat, high-calorie meal did not significantly affect the overall monomethyl fumarate plasma exposure (AUC), but decreased the C max of MMF by 20%, with prolonged absorption.

The median T max of MMF was delayed from approximately 4.0 hours to 11 hours by a high fat meal. Distribution From studies with dimethyl fumarate (the prodrug of BAFIERTAM), it is shown that the apparent volume of distribution of MMF varies between 53 and 73 L in healthy subjects. Human plasma protein binding of MMF is 27-45% and independent of concentration.

Elimination Metabolism In humans, metabolism of MMF occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP450) system. MMF, fumaric and citric acid, and glucose are the major metabolites of MMF in plasma. Excretion From studies with dimethyl fumarate (the prodrug of BAFIERTAM), exhalation of CO 2 is the primary route of elimination, accounting for approximately 60% of the dimethyl fumarate dose.

Renal and fecal elimination are minor routes of elimination for MMF, accounting for 16% and 1% of the dimethyl fumarate dose, respectively. Trace amounts of unchanged MMF were present in urine. The plasma half-life of MMF is approximately 0.5 hours and no circulating MMF is present at 24 hours in the majority of individuals following oral administration of BAFIERTAM 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions.

Accumulation of MMF does not occur with multiple doses of dimethyl fumarate. Specific Populations Body weight, gender, and age differences do not require dosage adjustment. No studies have been conducted in subjects with hepatic or renal impairment.

However, neither condition would be expected to affect plasma exposure to MMF and therefore, no dosage adjustment is necessary. Drug Interaction Studies No potential drug interactions with dimethyl fumarate or MMF were identified in in vitro CYP inhibition and induction studies, or in P-glycoprotein studies. Single doses of interferon beta-1a or glatiramer acetate did not alter the pharmacokinetics of MMF.

Aspirin, when administered approximately 30 minutes before dimethyl fumarate, did not alter the pharmacokinetics of MMF. Oral Contraceptives The coadministration of the prodrug of BAFIERTAM, dimethyl fumarate, with a combined oral contraceptive (norelgestromin and ethinyl estradiol) did not elicit any relevant effects in oral contraceptives exposure. No interaction studies have been performed with oral contraceptives containing other progestogens.

🧬 Pharmacodynamics 59 words ▾

12.2Pharmacodynamics Potential to prolong the QT interval In a placebo controlled thorough QT study performed in healthy subjects with dimethyl fumarate [the prodrug of BAFIERTAM], there was no evidence that dimethyl fumarate caused QT interval prolongation of clinical significance (i.e., the upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 ms).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of BAFIERTAM is based upon bioavailability studies in healthy subjects comparing oral dimethyl fumarate delayed-release capsules to BAFIERTAM delayed-release capsules [see Clinical Pharmacology ( 12.3 )]. The clinical studies described below were conducted using dimethyl fumarate. The efficacy and safety of dimethyl fumarate were demonstrated in two studies (Studies 1 and 2) that evaluated dimethyl fumarate taken either twice or three times a day in patients with relapsing-remitting multiple sclerosis (RRMS).

The starting dose for dimethyl fumarate was 120 mg twice or three times a day for the first 7 days, followed by an increase to 240 mg twice or three times a day. Both studies included patients who had experienced at least 1 relapse over the year preceding the trial or had a brain Magnetic Resonance Imaging (MRI) scan demonstrating at least one gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization. The Expanded Disability Status Scale (EDSS) was also assessed and patients could have scores ranging from 0 to 5.

Neurological evaluations were performed at baseline, every 3 months, and at the time of suspected relapse. MRI evaluations were performed at baseline, month 6, and year 1 and 2 in a subset of patients (44% in Study 1 and 48% in Study 2). Study 1: Placebo-Controlled Trial in RRMS Study 1 was a 2-year randomized, double-blind, placebo-controlled study in 1234 patients with RRMS.

The primary endpoint was the proportion of patients relapsed at 2 years. Additional endpoints at 2 years included the number of new or newly enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of Gd+ lesions, annualized relapse rate (ARR), and time to confirmed disability progression. Confirmed disability progression was defined as at least a 1 point increase from baseline EDSS (1.5 point increase for patients with baseline EDSS of 0) sustained for 12 weeks.

Patients were randomized to receive dimethyl fumarate 240 mg twice a day (n=410), dimethyl fumarate 240 mg three times a day (n=416), or placebo (n=408) for up to 2 years. The median age was 39 years, median time since diagnosis was 4 years, and median EDSS score at baseline was 2. The median time on study drug for all treatment arms was 96 weeks.

The percentages of patients who completed 96 weeks on study drug per treatment group were 69% for patients assigned to dimethyl fumarate 240 mg twice a day, 69% for patients assigned to dimethyl fumarate 240 mg three times a day, and 65% for patients assigned to placebo groups. Dimethyl fumarate had a statistically significant effect on all of the endpoints described above and the 240 mg three times daily dose showed no additional benefit over the dimethyl fumarate 240 mg twice daily dose. The results for this study (240 mg twice a day vs. placebo) are shown in Table 2 and Figure 1 .

Table 2: Clinical and MRI Results of Study 1 Dimethyl Fumarate 240 mg BID Placebo P-value Clinical Endpoints N=410 N=408 Proportion relapsing (primary endpoint) Relative risk reduction 27% 49% 46% <0.0001 Annualized relapse rate 0.172 0.364 <0.0001 Relative reduction 53 % Proportion with disability progression 16% 27% 0.0050 Relative risk reduction 38% MRI Endpoints N=152 N=165 Mean number of new or newly enlarging 2.6 17 <0.0001 T2 lesions over 2 years Percentage of subjects with no new or newly enlarging lesions 45% 27% Number of Gd+ lesions at 2 years 0.1 (0) 1.8 (0) Mean (median) Percentage of subjects with 0 lesions 93% 62% 1 lesion 5% 10% 2 lesions <1% 8% 3 to 4 lesions 0 9% 5 or more lesions <1% 11% Relative odds reduction (percentage) 90 % <0.0001 Mean number of new T1 hypointense lesions over 2 years 1.5 5.6 <0.0001 Figure 1: Time to 12-Week Confirmed Progression of Disability (Study 1) NOTE: Confirmed progression of disability is defined as at least 1.0 point increase on the EDSS from a baseline EDSS > =1.0 confirmed for 12 weeks or at least a 1.5 point increase on the EDSS from a basel… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~3 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (0, 25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors, squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day, leiomyosarcomas of the forestomach at 400 mg/kg/day in males and females, renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males, and renal tubule adenomas at 400 mg/kg/day in females.

Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of MMF (380 mg/day). In rats, oral administration of DMF (0, 25, 50, 100, and 150 mg/kg/day) for up to two years resulted in increases in squamous cell carcinomas and papillomas of the forestomach at all doses tested in males and females, and in testicular interstitial (Leydig) cell adenomas at 100 and 150 mg/kg/day. Plasma MMF AUC at the lowest dose tested was lower than that in humans at the RHD of MMF.

Mutagenesis Monomethyl fumarate (MMF) was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. MMF was clastogenic in the in vitro chromosomal aberration assay in human peripheral blood lymphocytes in the absence of metabolic activation. DMF was not clastogenic in the in vivo micronucleus assay in the rat.

Impairment of Fertility In male rats, oral administration of DMF (0, 75, 250, and 375 mg/kg/day) prior to and throughout the mating period had no effect on fertility; however, increases in non-motile sperm were observed at the mid and high doses. The no-effect dose for adverse effects on sperm is similar to the recommended human dose (RHD) of DMF (480 mg/day) on a body surface area (mg/m 2 ) basis. MMF (380 mg/day) is bioequivalent to DMF (480 mg/day).

In female rats, oral administration of DMF (0, 20, 100, and 250 mg/kg/day) prior to and during mating and continuing to gestation day 7 caused disruption of the estrous cycle and increases in embryolethality at the highest dose tested. The highest dose not associated with adverse effects (100 mg/kg/day) is twice the RHD for DMF on a mg/m 2 basis. MMF (380 mg/day) is bioequivalent to DMF (480 mg/day).

Testicular toxicity (germinal epithelial degeneration, atrophy, hypospermia, and/or hyperplasia) was observed at clinically relevant doses in mice, rats, and dogs in subchronic and chronic oral toxicity studies of DMF, and in a chronic oral toxicity study evaluating a combination of four fumaric acid esters (including DMF) in rats.

13.2Animal Toxicology and/or Pharmacology Kidney toxicity was observed after repeated oral administration of dimethyl fumarate (DMF) in mice, rats, dogs and monkeys. Renal tubule epithelia regeneration, suggestive of tubule epithelial injury, was observed in all species. Renal tubular hyperplasia was observed in rats with dosing for up to two years.

Cortical atrophy and interstitial fibrosis were observed in dogs and monkeys at doses above 5 mg/kg/day. In monkeys, the highest dose tested (75 mg/kg/day) was associated with single cell necrosis and multifocal and diffuse interstitial fibrosis, indicating irreversible loss of renal tissue and function. In dogs and monkeys, the 5 mg/kg/day dose was associated with plasma MMF exposures less than or similar to that in humans at the recommended human dose (RHD) of MMF (380 mg/day).

A dose-related increase in incidence and severity of retinal degeneration was observed in mice following oral administration of DMF for up to two years at doses above 75 mg/kg/day, a dose associated with plasma MMF exposure (AUC) similar to that in humans at the RHD of MMF (380 mg/day).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (0, 25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors, squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day, leiomyosarcomas of the forestomach at 400 mg/kg/day in males and females, renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males, and renal tubule adenomas at 400 mg/kg/day in females.

Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of MMF (380 mg/day). In rats, oral administration of DMF (0, 25, 50, 100, and 150 mg/kg/day) for up to two years resulted in increases in squamous cell carcinomas and papillomas of the forestomach at all doses tested in males and females, and in testicular interstitial (Leydig) cell adenomas at 100 and 150 mg/kg/day. Plasma MMF AUC at the lowest dose tested was lower than that in humans at the RHD of MMF.

Mutagenesis Monomethyl fumarate (MMF) was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. MMF was clastogenic in the in vitro chromosomal aberration assay in human peripheral blood lymphocytes in the absence of metabolic activation. DMF was not clastogenic in the in vivo micronucleus assay in the rat.

Impairment of Fertility In male rats, oral administration of DMF (0, 75, 250, and 375 mg/kg/day) prior to and throughout the mating period had no effect on fertility; however, increases in non-motile sperm were observed at the mid and high doses. The no-effect dose for adverse effects on sperm is similar to the recommended human dose (RHD) of DMF (480 mg/day) on a body surface area (mg/m 2 ) basis. MMF (380 mg/day) is bioequivalent to DMF (480 mg/day).

In female rats, oral administration of DMF (0, 20, 100, and 250 mg/kg/day) prior to and during mating and continuing to gestation day 7 caused disruption of the estrous cycle and increases in embryolethality at the highest dose tested. The highest dose not associated with adverse effects (100 mg/kg/day) is twice the RHD for DMF on a mg/m 2 basis. MMF (380 mg/day) is bioequivalent to DMF (480 mg/day).

Testicular toxicity (germinal epithelial degeneration, atrophy, hypospermia, and/or hyperplasia) was observed at clinically relevant doses in mice, rats, and dogs in subchronic and chronic oral toxicity studies of DMF, and in a chronic oral toxicity study evaluating a combination of four fumaric acid esters (including DMF) in rats.

📄 Patient Package Insert ~3 min read ▾

Patient Information BAFIERTAM ® (bah”feer'tam) (monomethyl fumarate) delayed-release capsules, for oral use What is BAFIERTAM? BAFIERTAM is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if BAFIERTAM is safe and effective in children.

Do not take BAFIERTAM if you: have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the ingredients in BAFIERTAM. See “WHAT ARE THE INGREDIENTS IN BAFIERTAM?” for a complete list of ingredients. are taking dimethyl fumarate or diroximel fumarate. Before taking and while you take BAFIERTAM, tell your doctor about all of your medical conditions, including if you: have liver problems have or have had low white blood cell counts or an infection are pregnant or plan to become pregnant.

It is not known if BAFIERTAM will harm your unborn baby. You and your doctor will have to decide if you should take BAFIERTAM while you are pregnant or if you plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if BAFIERTAM passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby while using BAFIERTAM. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take BAFIERTAM?

Take BAFIERTAM exactly as your doctor tells you to take it. You will be given 1 strength of BAFIERTAM when starting your treatment. The recommended starting dose is one 95 mg capsule taken by mouth 2 times a day for 7 days.

The recommended dose after 7 days is two 95 mg capsules taken by mouth 2 times a day. BAFIERTAM can be taken with or without food. Swallow BAFIERTAM capsules whole and intact.

Do not crush, chew, or mix the contents with food. If you take too much BAFIERTAM, call your doctor or go to the nearest hospital emergency room right away. What are the possible side effects of BAFIERTAM?

BAFIERTAM may cause serious side effects including: allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking BAFIERTAM and get emergency medical help right away if you get any of these symptoms. PML (progressive multifocal leukoencephalopathy), a rare brain infection that usually leads to death or severe disability over a period of weeks or months.

Tell your doctor right away if you get any of these symptoms of PML: weakness on one side of the body that gets worse vision problems confusion clumsiness in your arms or legs changes in thinking and memory personality changes herpes zoster infections (shingles), including central nervous system infections other serious infections decreases in your white blood cell count: Your doctor should do a blood test to check your white blood cell count before you start treatment with BAFIERTAM and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that. liver problems: Your doctor should do blood tests to check your liver function before you start taking BAFIERTAM and during treatment if needed.

Tell your doctor right away if you get any of these symptoms of a liver problem during treatment: severe tiredness loss of appetite pain on the right side of your stomach have dark or brown (tea color) urine yellowing of your skin or the white part of your eyes serious gastrointestinal problems, including bleeding, ulcers, blockage, and tears (perforation) of the stomach or intestines. Tell your healthcare provider right away if you have any of these symptoms during treatment: stomach-area pain that does not go away bright red or black stools (that look like tar) severe vomiting severe diarrhea coughing up blood or blood clots vo… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 32 words ▾

Principal Display Panel – Bottle Label 69387-001-01 120 capsules Rx only Bafiertam ® (monomethyl fumarate) Delayed-release capsules 95 mg Dispense in Original Package. Swallow capsules whole. Principal Display Panel – Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
135
Units reimbursed last 4 qtrs
21.5K
Gross reimbursed last 4 qtrs
$1.25M
Avg / prescription
$9,222.94
Avg / unit
$57.9654
Latest quarter Q1 2026
32Rx
Fee-for-service vs managed care ⓘ
62% FFS 38% MCO
Fee-for-service · 84 Rx Managed care · 51 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,560 units · 13.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 15,360 units · 39.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 4,560 units · 61.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.261.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 61.4 /100k
2 California 39.4 /100k
3 Ohio 13.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bafiertam — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bafiertam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.49M
Claims incl. refills
585
Beneficiaries
268
Spend / beneficiary
$16,761.42
Spend / claim
$7,678.73
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 BAFIERTAM (this brand).

Top reported reactions

Flushing348
Pruritus110
Nausea75
Abdominal Discomfort65
Erythema65
Abdominal Pain Upper51
Fatigue47

Age at onset

Adult6
Elderly1

Reporter sex

926 reports
Male · 13%
Female · 76%
Unknown · 11%

Serious outcomes

Hospitalization48
Death3
Disabling2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 227 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
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 ✓ Available
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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 Banner Life Sciences LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Banner Life Sciences 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.
← 69375-0006-60 · Nationwide 69389-0090-72 · US →
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.