Memantine Hydrochloride 28 mg Capsule, Extended Release, 90-count
by Apotex Corp · 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-9)
NDC 60505-6211-09
🏷️ FDA NDC (as labeled)
60505-6211-9
billing pads the package segment with a zero
This package
Also comes in:
30 capsules 60505-6211-03
Rx only
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Memantine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 24, 2026 — Failed Dissolution Specifications (The Harvard Drug Group LLC) · FDA recall D-0485-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
60505-6211-9
Product NDC
60505-6211
11-digit billing NDC
60505621109
NCPDP billing unit
EA — each (per item)
Application #
NDA022525
Mechanism of action
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Dec 2022)
Route
ORAL
Dosage form
CAPSULE, EXTENDED RELEASE
Substance
MEMANTINE HYDROCHLORIDE
GCN Seq No
070870
GCN
34527
HICL code
013778
Ingredient (HICL)
Memantine Hcl
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H1
Therapeutic class — intermediate (HIC2)
Drugs Affecting Principally The Brain
HIC3 code
H1A
Therapeutic class — specific (HIC3)
Alzheimer's Therapy, Nmda Receptor Antagonists
AHFS code
28:92.00.00
AHFS class
Central Nervous System Agents, Misc.
FDB label name
MEMANTINE HCL ER 28 MG CAPSULE
FDB brand name
Memantine Hcl Er
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 60505-6211-9 — a 5-4-1 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 package segment → 60505-6211-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerApotex Corp
Application holderABBVIE INC
FDA applicationNDA022525 (NDA)
Labeler code60505
Product typeHuman Prescription Drug
Portfolio53 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name MEMANTINE HCL ER 28 MG CAPSULE Ingredient Memantine Hcl
📖 What it is MedlinePlus · NLM
Memantine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that affects memory, thinking, and behavior). Memantine is in a class of medications called NMDA receptor antagonists. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Memantine helps manage the symptoms of moderate to severe Alzheimer's disease. It works by blocking certain brain receptors that are overstimulated in Alzheimer's, which is thought...
- What does memantine actually do for Alzheimer's disease?
- No — memantine can be taken with or without food, whichever is easier to stick with. For the extended-release capsule form, food does slightly affect the timing of when the drug pe...
- Just skip the missed dose and take your next dose at the regularly scheduled time. Never double up to make up for a missed one. If you've missed several days in a row, don't just r...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Memantine Hydrochloride — tap one for details:
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.
💬 Questions about memantine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.779 | $70.11 / 90 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
▼ Down 37% 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Memantine Hydrochloride 28 mg 16571-0855-03 | Rising | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| Memantine Hydrochloride 28 mg 59651-0407-30 | Aurobindo | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| Memantine Hydrochloride 28 mg 65162-0785-03 | Amneal | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| Memantine hydrochloride 28 mg 68382-0549-06 | Zydus | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| Memantine Hydrochloride 28 mg 69680-0164-30 | Vitruvias | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| Memantine Hydrochloride 28 mg 70436-0057-04 | Slate | 30 capsules | $0.379 | AB | Availability likely | save 51% |
| memantine hydrochloride 28 mg 68180-0249-02 | Lupin | 500 capsules | $0.438 | AB | Discontinued | save 44% |
| memantine hydrochloride 28 mg 00904-6735-61 | Major | 1 capsule | $0.488 | AB | Availability likely | save 37% |
| Memantine Hydrochloride 28 mgthis 60505-6211-09 | Apotex | 90 capsules | $0.779 | — | Discontinued | — |
| memantine hydrochloride 28 mg 00615-8264-39 | NCS | 30 capsules | — | AB | Discontinued | — |
| Memantine hydrochloride 28 mg 33342-0222-07 | Macleods | 30 capsules | — | AB | FDA listed | — |
| Memantine hydrochloride 28 mg 70771-1324-03 | Zydus | 30 capsules | — | AB | FDA listed | — |
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2010
First FDA approval
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
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 8039009 — method of use (U-539)
US 8039009 — method of use (U-539)
US 8039009 — method of use (U-539)
US 8039009 — method of use (U-539)
US 8039009*PED — drug product
US 8039009*PED — drug product
US 8039009*PED — drug product
US 8039009*PED — drug product
2010
2012
2014
2016
2018
2020
2022
2024
2026
2028
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 (8)
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8039009 ↗ | Method of use | U-539 | Mar 24, 2029 |
| US 8039009 ↗ | Method of use | U-539 | Mar 24, 2029 |
| US 8039009 ↗ | Method of use | U-539 | Mar 24, 2029 |
| US 8039009 ↗ | Method of use | U-539 | Mar 24, 2029 |
| US 8039009*PED ↗ | Drug product | — | Sep 24, 2029 |
| US 8039009*PED ↗ | Drug product | — | Sep 24, 2029 |
| US 8039009*PED ↗ | Drug product | — | Sep 24, 2029 |
| US 8039009*PED ↗ | Drug product | — | Sep 24, 2029 |
Common questions
Is there a generic version of MEMANTINE HCL ER 28 MG CAPSULE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for MEMANTINE HCL ER 28 MG CAPSULE. See the alternatives section for substitutable, lower-cost products.
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.
🔬 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 Memantine Hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 48%
Female · 52%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 60505-6211-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-3) | $0.7790 / ea | $23.37 | 2019-05-09 | Discontinued by firm |
| 60505-6211-09 You're viewing this | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-9) | $0.7790 / ea | $70.11 | 2019-05-09 | Discontinued by firm |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.7790 NADAC).
Pack size FAQ
What quantity is in NDC 60505-6211-09?
NDC 60505-6211-09 is a 90-count package — 90 capsule, extended release in 1 bottle.
What is the difference between NDC 60505-6211-09 and NDC 60505-6211-03?
Both are Memantine Hydrochloride 28 mg Capsule, Extended Release — the drug itself is identical. NDC 60505-6211-09 is the 90-count package, while NDC 60505-6211-03 is the 30 capsules package.
What NDC number is used to bill for this package of Memantine Hydrochloride 28 mg Capsule, Extended Release?
Bill NDC 60505-6211-09 — the 11-digit billing format is 60505621109. 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.
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC The FDA label for this product carries no photos. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 60505-6211-9, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 60505-6211-09, written without dashes as 60505621109. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 60505-6211-09, the first segment (60505) is the labeler code FDA assigned to Apotex Corp; the middle segment (6211) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (60505-6211-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Apotex Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.