Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Mag 440 Megnesium Oxide 440 mg Tablet, 40-count — NDC 28595-710-40 (Billing 28595-0710-40)
by Allegis Pharmaceuticals, LLC · 40 TABLET in 1 BOTTLE
This is a package of 40 tablets of Mag 440 Megnesium Oxide 440 mg Tablet from Allegis Pharmaceuticals, LLC, marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.
NDC 28595-0710-40
🏷️ FDA NDC (as labeled)
28595-710-40
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 28595-710-40 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 28595 labeler · 710 product · 40 package
- Package marketed since
- Jan 27, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 40 EA per package
- Barcode (UPC)
- 0328595710402
- Medicaid fills, this package
- 91 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
28595-710-40
Product NDC
28595-710
11-digit billing NDC
28595071040
NCPDP billing unit
EA — each (per item)
RxCUI
2707337
UNII
3A3U0GI71G
UPC
0328595710402
Application #
M001
SPL Set ID
2cb19dc0-115b-38b8-e063-6294a90a4aea
Established class (EPC)
Calculi Dissolution Agent; Osmotic Activity
Mechanism of action
Magnesium Ion Exchange Activity
Physiologic effect
Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption; Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-01-27
Route
ORAL
Dosage form
TABLET
Substance
MAGNESIUM OXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
48400020000316
GCN Seq No
087121
GCN
56963
HICL code
000609
Ingredient (HICL)
Magnesium Oxide
HIC1 code
C
Therapeutic class — broad (HIC1)
Electrolyte Balance/Metabolism/Nutrition
HIC2 code
C1
Therapeutic class — intermediate (HIC2)
Drugs Affecting Electrolyte Balance
HIC3 code
C1H
Therapeutic class — specific (HIC3)
Magnesium Salts Replacement
AHFS code
56:04.00.00
AHFS class
Antacids And Adsorbents
FDB label name
MAGNESIUM OXIDE 440 MG TABLET
FDB brand name
Magnesium Oxide
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 087121
- GCN: 56963
- GPI-14 (Medi-Span): 48400020000316
- HICL (First Databank): 000609
- AHFS class code: 56:04.00.00
- RxCUI (RxNorm): 2707337
Why two NDCs?
The FDA registers this code as 28595-710-40 — 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 → 28595-0710-40. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Magnesium compounds class.
Drug family (ATC)
Magnesium compounds, Osmotically acting laxatives, Magnesium
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name MAGNESIUM OXIDE 440 MG TABLET Ingredient Magnesium Oxide
📗 Our plain-language guide HelloPharmacist
- It's used to relieve acid indigestion and upset stomach. Some products, like Magnesium Oxide 400mg, are also used as a magnesium supplement. Check which use your product is labeled...
- For antacid use, the labels say 1 tablet twice a day or as directed by your doctor. For supplement use, the directions vary by product, from 1 tablet daily to 1 to 2 tablets daily....
- The dietary supplement tablet suggests taking it preferably with food. The other labels don't give a food instruction, so follow what's on your package or what your prescriber tell...
- The main one is a laxative effect, meaning looser or more frequent stools. If that bothers you or you're using more than the label allows, check in with your doctor or pharmacist.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Megnesium Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $11.91 | $476.39 / 40 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 28595-0710-40 You're viewing this Main listing | 40 TABLET in 1 BOTTLE | 2025-01-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mag 440 440 mgthis 28595-0710-40 | Allegis | 40 tablets | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
- FDA Orange Book · refreshed Oct 3, 2026
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 Magnesium Oxide 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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII HZ58M6D839
A synthetic polymer made from ethylene, polyethylene oxide serves as a binder and thickener in medications. It helps hold solid formulations together and can increase viscosity in liquid products.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCroscarmellose Sodium, Microcrystalline Cellulose, Stearic Acid, Megnesium Stearate, Coating composition: Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, PEG.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerAllegis Pharmaceuticals, LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code28595
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio10 products on file
More NDCs from Allegis Pharmaceuticals, LLC labeler code 28595
- Nitroglycerin Lingual 400 ug Spray NDC 28595-120-12
- Urimar-T Caps methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate 120 mg; 40.8 mg; 36.2 mg; 10.8 mg; .12 mg Capsule NDC 28595-224-60
- Mb Caps methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate 120 mg; 40.8 mg; 36.2 mg; 10.8 mg; .12 mg Capsule NDC 28595-299-60
- HISTEX-DM New Formulation DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI 20 mg/5mL; 30 mg/5mL; 2.5 mg/5mL Syrup NDC 28595-310-16
- sulfacetamide sodium and sulfur Sodium Sulfacetamide - 90 mg/mL; 42.5 mg/mL Suspension NDC 28595-501-08
- Spinosad 9 mg/mL Suspension NDC 28595-570-04
- HISTEX TRIPROLIDINE HYDROCHLORIDE 2.5 mg/5mL Syrup NDC 28595-802-08
- HISTEX-DM DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE 20 mg/5mL; 10 mg/5mL; 2.5 mg/5mL Syrup NDC 28595-804-16
- HISTEX PD Drops New Formulation TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL Syrup NDC 28595-809-30
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 How Supplied / Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Relieves: Acid indigestion and upset stomach
⏱️ Dosage and Administration ▾
Directions Antacid Directions : take 1 tablet trice a day or as directed by a Physician. Magnesium Supplement Directions : Take 1 or 2 tablets day or as directed by a Physician.
⚠️ Warnings ▾
Warnings Ask a dcotor before use if you have kidney disease. Ask a doctor or pharmacist before use if you are taking a presciption drug. Antacid may interact with certian prescription drugs.
Do not take more than 2 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks, except under the advise and supervision of a physician. If Pregnant or breast-feeding , ask a professional before use. Keep out of the reach of children.
📦 How Supplied / Storage and Handling ▾
How Supplied Manufactured For: Allegis Pharmaceuticals, LLC Canton, MS 39046 www.allegispharma.com Rev 12/2024
🧪 Active Ingredient ▾
Drug Facts Active Ingredient (in each tablet)..........................................................Purpose Megnesium Oxide 440 mg (265.3 mg Elemental Magnesium).............Antacid
🧪 Inactive Ingredients ▾
Inactive ingredients Croscarmellose Sodium, Microcrystalline Cellulose, Stearic Acid, Megnesium Stearate, Coating composition: Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, PEG.
🎯 Purpose ▾
Purpose Purpose: Antacid
📄 Keep Out of Reach of Children ▾
Keep out of reach of children
📄 Other Information ▾
Other Information Magnesium content per tablet: 265.3 mg Store at controlled room temperature 59 - 86 F (15 - 30 C) Do not use if imprinted safety seal under cap is broken or missing.
📄 Questions or Comments ▾
Questions? Comments? Call 1-601-859-0038
📄 Package Label / Principal Display Panel ▾
Packaging Label
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.
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.
📅 Q2 2025 – Q1 2026 · 4 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
91
Units reimbursed last 4 qtrs
3.3K
Gross reimbursed last 4 qtrs
$39.3K
Avg / prescription
$431.90
Avg / unit
$11.9098
Latest quarter Q1 2026
19Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 56 Rx Managed care · 35 Rx
State Medicaid map
Units reimbursed · per 100k residents
4.857.3
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
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 Mag 440 (this brand).
Top reported reactions
Reporter sex
Male · 43%
Female · 57%
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.
About this NDC listing & data coverage
Over-the-counter (OTC) 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Allegis Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allegis Pharmaceuticals, 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
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.