NDC 52747-0621-30 — Concept DHA Vitamin- Mineral Omega-3

🆔 Identity & classification

FDA NDC (as labeled) 52747-621-30

Product NDC 52747-621

11-digit billing NDC 52747062130

NCPDP billing unit EA — each (per item)

UNII R5L488RY0Q, E1UOL152H7, PQ6CK8PD0R, 935E97BOY8, 8K0I04919X, TLM2976OFR +9 more

SPL Set ID bd2051f7-b887-46f6-8d4a-b099fcd08629

Established class (EPC) Vitamin C; Nicotinic Acid; Vitamin B12

Chemical class Ascorbic Acid; Nicotinic Acids; Vitamin B 12

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2009-06-24

Route ORAL

Dosage form CAPSULE, LIQUID FILLED

Substance FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; ZINC SULFATE, UNSPECIFIED FORM; OMEGA

GPI-14 78512091000135

GPI class Concept DHA

GCN Seq No 065127

GCN 21574

HICL code 036292

Ingredient (HICL) Mvn-Min75/Iron/Iron Ps/Om3/Dha

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C6

Therapeutic class — intermediate (HIC2) Vitamins

HIC3 code C6Z

Therapeutic class — specific (HIC3) Multivitamin Preparations

AHFS code 20:04.04.00

AHFS class Iron Preparations

FDB label name CONCEPT DHA CAPSULE

FDB brand name Concept Dha

Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation

Why two NDCs? The FDA registers this code as 52747-621-30 — 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 → 52747-0621-30. 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

LabelerU.S. Pharmaceutical Corporation

Labeler code52747

First marketedJun 2009

Product typeHuman Prescription Drug

Portfolio7 products on file

🔎 All NDCs from U.S. Pharmaceutical Corporation

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 CONCEPT DHA CAPSULE Ingredient Mvn-Min75/Iron/Iron Ps/Om3/Dha

🧪 What is this product?

Concept DHA is an oral liquid-filled capsule containing a combination of vitamins, minerals, and omega-3 fatty acids. The product includes B vitamins (thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, and cyanocobalamin), vitamin C, and folic acid, which are typically used to support energy metabolism and general nutritional needs. It also contains iron, zinc, copper, and magnesium, minerals commonly included in prenatal and general wellness supplements. The formulation includes omega-3 fatty acids and DHA (docosahexaenoic acid), components typically found in nutritional supplements. This product is marketed without an approved FDA application.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color pink

ShapeCapsule

ImprintConcept;DHA;US

Size22 mm

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 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 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 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 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

4 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.

💲 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	$1.059	$31.78 / 30 capsules
Medicaid paysCMS SDUD · 12 mo	$0.9410	$28.23 / 30 capsules
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

Flat over the last 9 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
Concept DHA 17.5 mg/1; 17.5 mg/1; 25 mg/1; 1 mg/1; 2 mg/1; 3 mg/1; 1.8 mg/1; 5 mg/1; 25 mg/1; 300 ug/1; 12.5 ugthis 52747-0621-30	U.S.	30 capsules	$1.059	—	Availability likely	—

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

🏛️

2009

On the market since

Jun 2009

📍

2026

Currently FDA-listed

17 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.

🗺️ 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 52747-0621-30, 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.

📅 Q3 2025 – Q4 2025 · 2 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

493

Units reimbursed last 4 qtrs

15.5K

Gross reimbursed last 4 qtrs

$14.6K

Avg / prescription

$29.60

Avg / unit

$0.9410

Latest quarter Q4 2025

327Rx

Medicaid pays / ea

$0.9410

gross reimbursed

vs

NADAC / ea

$1.0594

acquisition cost

=

Spread

−$0.1184

-11% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

32% FFS 68% MCO

Fee-for-service · 157 Rx Managed care · 336 Rx

State Medicaid map

Units reimbursed · per 100k residents

4.292.2

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 Alabama 92.2 /100k

2 Florida 40.3 /100k

3 Oklahoma 30.3 /100k

4 North Carolina 4.2 /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 · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Concept DHA — 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 Concept DHA. 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.

Total Part D spend

$613.21

Claims incl. refills

12

Beneficiaries

—

Spend / beneficiary

—

Spend / claim

$51.10

💵 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 Concept DHA (this brand).

Top reported reactions

Premature Delivery6

Nausea3

Pruritus3

Peripheral Swelling2

Pregnancy2

Preterm Premature Rupture Of Membranes2

Vomiting2

Age at onset

Adult7

Elderly1

Reporter sex

Serious outcomes

Life-threatening1

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	Marketing start	Status
52747-0621-30 You're viewing this	30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (52747-621-30)	2009-06-24	Active

🧭 About this NDC listing & data coverage

Finished prescription 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)	✓ Available
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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

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 52747-621-30, 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: 52747-0621-30, written without dashes as 52747062130. 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 52747-0621-30, the first segment (52747) is the labeler code FDA assigned to U.S. Pharmaceutical Corporation; the middle segment (0621) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

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 U.S. Pharmaceutical Corporation. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

U.S. Pharmaceutical Corporation 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.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings and Cautions 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 48 words ▾

INDICATIONS: Concept DHATM is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept DHATM may also be used to improve the nutritional status of women before conception.

⏱️ Dosage and Administration 37 words ▾

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

⚠️ Warnings and Cautions 135 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.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS: General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED: Concept DHA TM are red maroon opaque Vcaps ® capsules printed in white with "Concept DHA" on the cap "US" logo on the body. Packed in child-resistant cap and light resistant bottle of 30 capsules (52747-0621-30). The listed product number is not a National Drug Code.

Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Vcaps ® and the Vcaps ® Logo are trademarks used under license.

📋 Description ~3 min read ▾

DESCRIPTION: Each capsule contains: Ferrous Fumarate (Elemental Iron) . . . . . . . . . . 17.5 mg PolysaccharideIronComplex(ElementalIron).. 17.5mg (Equivalent to about 35 mg of elemental iron) Vitamin C (from ProAscorb C‡) . . . . . . . . . . . .

25 mg FolicAcid.............................. 1mg ThiamineMononitrate(B1) ................ 2mg Riboflavin(B2) ..........................

3mg Niacin (B3, from ProAscorb C‡) . . . . . . . . . . . . 1.8 mg d-CalciumPantothenate(B5)................ 5mg PyridoxineHCI(B6) ....................

25mg Biotin (B7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mcg Cyanocobalamin(B12) ................ 12.5mcg Copper(asCopperSulfate)..................

2mg Magnesium(asMagnesiumSulfate) . . . . . . . . Zinc(asZincSulfate).................... Omega-3 Fatty Acids . . . . . . . . . ...........

(Derived from 310 mg Fish Oil) Docosahexaenoic Acid (DHA) . ........... Eicosapentaenoic Acid (EPA) . ........... . 5mg 10mg 200 mg156 mg 39 mg Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous.

Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M.

Aikman and R.E. Rush, Springborn Laboratories, Inc. Spencerville, Ohio Study No.

3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Picinni, L.-Ricciotti, M.

1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No.

3, pp. 213-220 (July - September 1982). As mentioned above, the patented source of iron used in Concept DHATM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress.

CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone. INDICATIONS: Concept DHATM is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers.

Concept DHATM may also be used to improve the nutritional status of women before conception. 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. WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

WAR…

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

🔗 Related NDC lookups

🧪 All Vitamin- Mineral Omega-3 Supplement NDCsSame ingredient 🏭 All U.S. labeler NDCsLabeler code 52747 📚 All Calculi Dissolution Agent NDCsDrug class

Concept DHA Vitamin- Mineral Omega-3 Supplement 17.5 mg; 17.5 mg; 25 mg; 1 mg; 2 mg; 3 mg; 1.8 mg; 5 mg; 25 mg; 300 ug; 12.5 ug Capsule, Liquid Filled, 30-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups