Home › NDC Lookup › Ingredients › Ferrous Sulfate › 54738-0963-01
Ferrous Sulfate 325 mg Tablet, 100-count — NDC 54738-0963-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ferrous Sulfate 325 mg Tablet, 100-count — NDC 54738-963-01 (Billing 54738-0963-01)

by Richmond Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Ferrous Sulfate 325 mg Tablet from Richmond Pharmaceuticals, Inc., marketed since Jun 2015 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 54738-0963-01
🏷️ FDA NDC (as labeled) 54738-963-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Main listing for product 54738-963 · Also comes in: 100 tablets 54738-963-13 1000 tablets 54738-963-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 54738-963-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54738 labeler · 963 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 5473896301 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54738-963-01
Product NDC 54738-963
11-digit billing NDC 54738096301
NCPDP billing unit EA — each (per item)
RxCUI 310325
UNII 39R4TAN1VT
SPL Set ID 58dd4f30-980b-44bc-9f8e-8d4626854b91
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-06-01
Route ORAL
Dosage form TABLET
Substance FERROUS SULFATE

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

GPI-14 82300010000332
GPI class Ferrous Sulfate
GCN Seq No 001645
GCN 04695
HICL code 000739
Ingredient (HICL) Ferrous Sulfate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3B
Therapeutic class — specific (HIC3) Iron Replacement
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name FERROUS SULFATE 325 MG TABLET
FDB brand name Ferrous Sulfate
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 001645
  • GCN: 04695
  • GPI-14 (Medi-Span): 82300010000332
  • HICL (First Databank): 000739
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 310325
Why two NDCs? The FDA registers this code as 54738-963-01 — 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 → 54738-0963-01. 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 Iron bivalent, oral preparations class.

Drug family (ATC) Iron bivalent, oral preparations
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 FERROUS SULFATE 325 MG TABLET Ingredient Ferrous Sulfate
📖 About the active ingredient: Ferrous Sulfate MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Iron (as ferrous fumarate, ferrous gluconate, or ferrous sulfate) is used to treat or prevent anemia (a lower-than-normal number of red blood cells) when the amount of iron taken in from your diet is not enough. Iron is a mineral that is available as a dietary supplement. It works by providing iron to help the body to produce red blood cells.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an oral tablet containing 325 milligrams of ferrous sulfate, a form of iron commonly used as a dietary supplement to help address iron deficiency. Iron is an essential mineral that supports the body's ability to carry oxygen in the blood and produce energy. This product is marketed as an unapproved over-the-counter drug and has not received an FDA-approved application.

Supplement & herbal interactions

Some supplements/herbs that may interact with Ferrous Sulfate — tap one for details:

ArumMinor Liver ExtractMinor
🌿 Every supplement checked against Ferrous Sulfate (2 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 1000 tablets
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
54738-0963-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2015-06-01 — Active
54738-0963-03 54738-963-03 1000 TABLET in 1 BOTTLE 2015-06-01 — Active
54738-0963-13 54738-963-13 100 TABLET in 1 BOTTLE 2008-11-05 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 54738-0963-13?
Both are Ferrous Sulfate 325 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 54738-0963-13 is the 100 tablets package.
What NDC number is used to bill for this package of Ferrous Sulfate 325 mg Tablet?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ferrous Sulfate 325 mgthis 54738-0963-01 Richmond 100 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Jun 2015
📍
2026
Currently FDA-listed
11 years 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.

What it looks like

Color red
ShapeRound
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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 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.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCroscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

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.

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

LabelerRichmond Pharmaceuticals, Inc.
Labeler code54738
First marketedJun 2015
Product typeHuman Otc Drug
Portfolio21 products on file

More NDCs from Richmond Pharmaceuticals, Inc. labeler code 54738

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 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

SUGGESTED USE Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor.

⏱️ Dosage and Administration 34 words ▾

DOSAGE AND ADMINISTRATION Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

⚠️ Warnings 104 words ▾

WARNING: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children . In case of accidental overdose, call a doctor or Poison Control Center immediately.

WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals.

Iron-containing medication may occasionally cause constipation or diarrhea. As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.

🧪 Active Ingredient 25 words ▾

Active Ingredient EACH TABLET CONTAINS: % U.S. RDA* Elemental Iron 65 mg 360 (Equivalent to 325 mg of Ferrous Sulfate) * U.S. Recommended Daily Allowance

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Iron Supplement

📄 Keep Out of Reach of Children 27 words ▾

DRUG INTERACTION PRECAUTION Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

📄 Questions or Comments 25 words ▾

Questions or Comments DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS MISSING OR DAMAGED Call 804-270-4498 Monday-Friday, 8.30 am – 4.30 pm ET

📄 Package Label / Principal Display Panel 22 words ▾

Package Label FERROUS SULFATE TABLETS 325 mg (5 gr) Iron Supplement NDC: 54738-963-01 – 100 Tablets NDC: 54738-963-03 – 1000 TABLETS IMG_4683

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for FERROUS SULFATE — the ingredient across all brands.

Top reported reactions

Fatigue3,518
Diarrhoea3,270
Nausea2,879
Dyspnoea2,867
Death2,442
Acute Kidney Injury2,125
Headache2,055

Age at onset

Neonate130
Infant70
Child200
Adolescent234
Adult4,185
Elderly5,242

Reporter sex

49,924 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization21,517
Death5,593
Life-threatening2,038
Disabling1,167
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,092 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

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Richmond Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 tablets (54738-0963-13), 1000 tablets (54738-0963-03). 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?
Richmond Pharmaceuticals, Inc. 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.
← 54738-0559-03 · Richmond 54738-0973-12 · Richmond →
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.