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Dimethyl Fumarate 240 mg Capsule, Delayed Release, 60-count — NDC 16729-417-12 (Billing 16729-0417-12)

by Accord Healthcare Inc. · 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 60 capsules of Dimethyl Fumarate 240 mg Capsule, Delayed Release from Accord Healthcare Inc., marketed since Jan 2021 and currently FDA-listed; retail pharmacies pay about $0.4555 per capsule (NADAC). It is the main listing for this product, which comes in 4 package sizes.

NDC 16729-0417-12
🏷️ FDA NDC (as labeled) 16729-417-12 billing pads the product segment with a zero
This package
Contains60-count Cost per ea$0.4555 NADAC Per package$27.33 / 60 capsules Pack sizes4 compare ↓
Main listing for product 16729-417 · Also comes in: 46 capsules 16729-417-27 180 capsules 16729-417-59 500 capsules 16729-417-16
Rx only Generic 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 16729-417-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
16729 labeler · 417 product · 12 package
Package marketed since
Jan 13, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 1672941712 9
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16729-417-12
Product NDC 16729-417
11-digit billing NDC 16729041712
NCPDP billing unit EA — each (per item)
Application # ANDA210499
SPL Set ID 5bb2bc09-0013-117d-e063-6294a90a24e4
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-13
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance DIMETHYL FUMARATE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 070787
GCN 34435
HICL code 040168
Ingredient (HICL) Dimethyl 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 DIMETHYL FUMARATE DR 240 MG CP
FDB brand name Dimethyl Fumarate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070787
  • GCN: 34435
  • HICL (First Databank): 040168
  • AHFS class code: 90:04.08.00
Why two NDCs? The FDA registers this code as 16729-417-12 — 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 → 16729-0417-12. 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

Label name DIMETHYL FUMARATE DR 240 MG CP Ingredient Dimethyl Fumarate
📖 What it is MedlinePlus · NLM

Dimethyl fumarate is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Dimethyl fumarate is in a class of medications called...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The oral capsules are for relapsing forms of multiple sclerosis in adults. That includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive...
  • You take them by mouth twice a day. Most people start on a lower dose for the first week and then move up. Swallow them whole, and do not crush, chew or sprinkle them on food. Take...
  • Flushing is the most common, along with stomach pain, diarrhea and nausea. Taking the capsules with food can help the flushing. Your doctor may also suggest a non-enteric coated as...
  • Get emergency help for swelling of the face, lips or throat or trouble breathing, and do not take another dose. Call right away for new neurologic symptoms, signs of a serious infe...
📖 Read our full Dimethyl Fumarate guide →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.456 $27.33 / 60 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Dec 2023 Jan 2026 May 2026 $3.055 $0.456
▼ Down 85% over the last 12 months.
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 Per unit Per pack Marketing startMarketing endStatus
16729-0417-12 You're viewing this Main listing 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.4555 / ea $27.33 2021-01-13 — Active
16729-0417-59 16729-417-59 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.9841 / ea $177.14 2021-01-20 — Active
16729-0417-16 16729-417-16 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2022-09-26 — Active
16729-0417-27 16729-417-27 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2022-09-26 — Active

You're viewing one of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.4555 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 capsule, delayed release in 1 bottle.
How does this package differ from NDC 16729-0417-27?
Both are Dimethyl Fumarate 240 mg Capsule, Delayed Release — the drug itself is identical. This page's package is the 60-count one, while NDC 16729-0417-27 is the 46 capsules package.
What NDC number is used to bill for this package of Dimethyl Fumarate 240 mg Capsule, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dimethyl Fumarate 240 mgthis 16729-0417-12 Accord 60 capsules $0.456 AB Availability likely —
Dimethyl Fumarate 240 mg 33342-0350-09 Macleods 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 43547-0025-06 Solco 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 43598-0430-60 Dr. 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 59651-0084-60 Aurobindo 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 69097-0323-03 Cipla 60 capsules $0.467 — Availability likely +3%
Dimethyl Fumarate 240 mg 69238-1319-06 Amneal 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 70512-0853-60 SOLA 60 capsules $0.467 AB Availability likely +3%
Dimethyl Fumarate 240 mg 82009-0138-60 Quallent 60 capsules $0.467 AB Availability likely +3%
Dimethyl fumarate 240 mg 82249-0747-60 CivicaScript 60 capsules $0.467 AB Availability likely +3%
dimethyl fumarate 240 mg 24979-0128-02 Upsher-Smith 500 capsules — AB FDA listed —
Dimethyl Fumarate 240 mg 31722-0658-31 Camber 46 capsules — AB FDA listed —
Dimethyl Fumarate 240 mg 50090-5288-00 A-S 1 capsule — AB FDA listed —
dimethyl fumarate 240 mg 51407-0441-60 Golden 60 capsules — AB FDA listed —
Tecfidera 240 mg 64406-0006-02 Biogen 60 capsules — AB FDA listed —
Dimethyl fumarate 240 mg 67877-0556-10 Ascend 1000 capsules — AB FDA listed —
Dimethyl Fumarate 240 mg 68462-0308-05 Glenmark 500 capsules — AB FDA listed —
Dimethyl Fumarate 240 mg 69539-0043-05 MSN 500 capsules — AB FDA listed —
dimethyl fumarate 240 mg 70710-1205-06 Zydus 60 capsules — — FDA listed —
dimethyl fumarate 240 mg 70771-1531-06 Zydus 60 capsules — — FDA listed —
Dimethyl Fumarate 240 mg 84677-0030-60 Golden 60 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Dimethyl 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.

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

LabelerAccord Healthcare Inc.
Application holderACCORD HEALTHCARE INC
FDA applicationANDA210499 (ANDA)
Labeler code16729
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio143 products on file

More NDCs from Accord Healthcare Inc. labeler code 16729

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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

Medicare Part D (outpatient prescription) spending for Dimethyl Fumarate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ 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 Dimethyl Fumarate. 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
$10.94M
Claims incl. refills
14.9K
Beneficiaries
6.3K
Spend / beneficiary
$1,737.88
Spend / claim
$733.91
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.
← 16729-0416-04 · Accord 16729-0421-01 · Accord →
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.