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Tricon 15 ug; 110 mg; 75 mg; .5 mg Capsule, 100-count — NDC 63044-0635-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tricon 15 ug; 110 mg; 75 mg; .5 mg Capsule, 100-count — NDC 63044-635-10 (Billing 63044-0635-10)

by Nnodum Pharmaceuticals · 10 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK

This is a package of 100 capsules of Tricon 15 ug; 110 mg; 75 mg; .5 mg Capsule from Nnodum Pharmaceuticals, marketed since May 2005 and currently FDA-listed. It is this product's only package size.

NDC 63044-0635-10
🏷️ FDA NDC (as labeled) 63044-635-10 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 63044-635-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63044 labeler · 635 product · 10 package
Package marketed since
May 20, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0363044635011
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63044-635-10
Product NDC 63044-635
11-digit billing NDC 63044063510
NCPDP billing unit EA — each (per item)
RxCUI 999799
UNII P6YC3EG204, R5L488RY0Q, PQ6CK8PD0R, 935E97BOY8
UPC 0363044635011
SPL Set ID d891ab47-4a05-4b5b-b372-7ddf91699c29
Established class (EPC) Vitamin B12; Vitamin C
Chemical class Vitamin B 12; Ascorbic Acid
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-05-20
Route ORAL
Dosage form CAPSULE
Substance CYANOCOBALAMIN; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID

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

GPI-14 82992005250130
GPI class Tricon
GCN Seq No 038271
GCN 58912
HICL code 000667
Ingredient (HICL) Ferrous Fum/Vit C/B12-If/Folic
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 TRICON CAPSULE
FDB brand name Tricon
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 038271
  • GCN: 58912
  • GPI-14 (Medi-Span): 82992005250130
  • HICL (First Databank): 000667
  • AHFS class code: 20:04.04.00
  • RxCUI (RxNorm): 999799
Why two NDCs? The FDA registers this code as 63044-635-10 — 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 → 63044-0635-10. 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 Vitamin B12 class.

Pharmacologic class Vitamin B12
Drug family (ATC) Vitamin B12 (cyanocobalamin and analogues)
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 TRICON CAPSULE Ingredient Ferrous Fum/Vit C/B12-If/Folic
🧪 What is this product?

Tricon is an oral capsule containing four active ingredients: ascorbic acid (vitamin C), cyanocobalamin (vitamin B12), ferrous fumarate (an iron salt), and folic acid (vitamin B9). These ingredients are typically used as nutritional supplements to help support or correct deficiencies in these vitamins and minerals. This product is marketed without an approved FDA application.

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.

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.
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
63044-0635-10 You're viewing this Main listing 10 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK 2005-05-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tricon 15 ug/1; 110 mg/1; 75 mg/1; .5 mgthis 63044-0635-10 Nnodum 100 capsules — — 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

🏛️
2005
On the market since
May 2005
📍
2026
Currently FDA-listed
21 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 Brown
ShapeCapsule
ImprintN635
Size16 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

13 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.

Manufacturer & labeler

LabelerNnodum Pharmaceuticals
Labeler code63044
First marketedMay 2005
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Nnodum Pharmaceuticals labeler code 63044

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

INDICATIONS AND USAGE TRICON™ is a multifactor preparation effective in the treatment of anemias that respond to oral hematinics, including pernicious anemia and other megaloblastic anemias and also irondeficiency anemia. Therapeutic quantities of hematopoietic factors that are known to be important are present in the recommended daily dose.

⏱️ Dosage and Administration 23 words ▾

DOSAGE AND ADMINISTRATION One capsule twice a day. (Two capsules daily produce a standard response in the average uncomplicated case of pernicious anemia.)

⛔ Contraindications 9 words ▾

CONTRAINDICATIONS Hemochromatosis and hemosiderosis are contraindications to iron therapy.

🤒 Adverse Reactions 63 words ▾

ADVERSE REACTIONS Rarely, iron in therapeutic doses produces gastrointestinal reactions, such as diarrhea or constipation. Reducing the dose and administering it with meals will minimize these effects in the iron-sensitive patient. In extremely rare instances, skin rash suggesting allergy has been noted following the oral administration of liver-stomach material.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

🤰 Pregnancy 50 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with TRICON™ Capsules. It is also not known whether TRICON™ Capsules can cause fetal harm when administered to pregnant women or can affect reproduction capacity. TRICON™ Capsules should be given to pregnant women only if clearly needed.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 have not been established.

🧓 Geriatric Use 72 words ▾

Geriatric Use Geriatric Use: Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 52 words ▾

OVERDOSAGE Symptoms: Those of iron intoxication, which may include pallor and cyanosis, vomiting, hematemesis, diarrhea, melena, shock, drowsiness, and coma. Treatment: For specific therapy, exchange transfusion and chelating agents. For general management, gastric and rectal lavage with sodium bicarbonate solution or milk, administration of intravenous fluids and electrolytes, and use of oxygen.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY: Vitamin B12 with Intrinsic Factor: when secretion of intrinsic factor in gastric juice is inadequate or absent (e.g., Addisonian pernicious anemia or after gastrectomy), vitamin B12 in physiologic doses is absorbed poorly, if at all. The resulting deficiency of vitamin B12 leads to the clinical manifestations of pernicious anemia. Similar megaloblastic anemias may develop in fish tapeworm ( Diphyllobothrium latum ) infection or after a surgically created small bowel blind loop; in these situations, treatment requires freeing the host of the parasites or bacteria that appear to compete for the available vitamin B12.

Strict vegetarianism and malabsorption syndromes may also lead to vitamin B12 deficiency. In the latter case, parenteral therapy or oral therapy with so-called massive doses of vitamin B12 may be necessary for adequate treatment of the patient. Potency of intrinsic factor concentrates is determined physiologically, i.e., by their use in patients with pernicious anemia.

The liver-stomach concetrate with intrinsic factor and the vitamin B12 contained in two TRICON™ Capsules provide 1½ times the minimum amount of therapeutic agent that, when given daily in an uncomplicated case of pernicious anemia, will produce a satisfactory response and relief of anemia and symptoms. Concentrates of intrinsic factor derived from hog gastric, pyloric, and duodenal mucosa have been used successfully in patients who lack intrinsic factor. Folic Acid: Folic acid deficiency is the immediate cause of most, if not all, cases of nutritional megaloblastic anemia and of the megaloblastic anemias of pregnancy and infancy; usually, it is also at least partially responsible for the megaloblastic anemias of malabsorption syndromes, e.g., tropical and nontropical sprue.

It is apparent that in vitamin B12 deficiency (e.g., pernicious anemia) lack of this vitamin results in impaired utilization of folic acid. There are other evidences of the close folic acid-vitamin B12 interrelationship: (1) B12 influences the storage, absorption, and utilization of folic acid, and (2) as a deficiency of B12 progresses, the requirement for folic acid increases. However, folic acid does not change the requirements for vitamin B12.

Iron: A very common anemia is that due to iron deficiency. In most cases, the response to iron salts is prompt, safe, and predictable. Within limits, the response is quicker and more certain to large doses of iron than to small doses.

Each TRICON™ (hematinic concentrate with intrinsic factor) Capsule furnishes 110 mg of elemental iron (as ferrous fumarate) to provide a maximum response. Ascorbic Acid: Vitamin C plays a role in anemia therapy. It augments the conversion of folic acid to its active form, folinic acid.

In addition, ascorbic acid promotes the reduction of ferric iron in food to the more readily absorbed ferrous form. Severe and prolonged vitamin C deficiency is associated with an anemia that is usually hypochromic but occasionally megaloblastic in type.

📦 How Supplied / Storage and Handling 52 words ▾

HOW SUPPLIED TRICON™ Capsules are opaque brown NDC 63044-0635-10 Unit Dose Packs containing 10 capsules per card. 100 capsules. Storage: Store at controlled room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature. Manufactured For Nnodum Pharmaceuticals by Contract Pharmacal Corporation 135 Adams Avenue Hauppauge, New York 11788

📋 Description 162 words ▾

DESCRIPTION Each TRICON™ Capsule contains: Special liver-stomach concentrate (containing intrinsic factor). . . . . . . . . . . . . . . . 240 mg Vitamin B12 (activity equivalent) . . . . . . . . . . . .15 mcg Iron, elemental (ferrous fumarate) . . . . . . . . . .110 mg Vitamin C (ascorbic acid) . . . . . . . . . . . . . . . . . 75 mg Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . .

0.5mg with other factors of vitamin B complex present in the liver-stomach concentrate. Inactive ingredients: Citric acid, D&C Yellow No. 10, ethylcellulose, FD&C Blue No.

1, FD&C Red #28, gelatin, lecithin, magnesium stearate, pharmaceutical glaze, silicon dioxide, simethicone, sodium benzoate, sodium citrate, sorbic acid, starch, and titanium dioxide.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. Folic acid alone is unwarranted in the treatment of pure vitamin B12 deficiency states, such as pernicious anemia. Folic acid may obscure pernicious anemia in that the blood picture may revert to normal while neurological manifestations remain progressive.

As with all preparations containing intrinsic factor, resistance may develop in some cases of pernicious anemia to the potentiation of absorption of physiologic doses of vitamin B12. If resistance occurs, parenteral therapy or oral therapy with so-called massive doses of vitamin B12 may be necessary for adequate treatment of the patient. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.

Periodic clinical and laboratory studies are considered essential and are recommended. Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with TRICON™ Capsules. It is also not known whether TRICON™ Capsules can cause fetal harm when administered to pregnant women or can affect reproduction capacity.

TRICON™ Capsules should be given to pregnant women only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRICON™ is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 have not been established. Geriatric Use Geriatric Use: Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

🍼 Nursing Mothers 34 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRICON™ is administered to a nursing woman.

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC 63044-635-01 Tricon Capsules 100 Capsules Manufactured for Nnodum Pharmaceuticals Corp. 483 Northland Blvd., Cincinnati, OH 45240 res Tricon 635-01

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 TRICON — the ingredient across all brands.

Top reported reactions

Death2
Headache2
Abdominal Pain1
Activities Of Daily Living Impaired1
Acute Kidney Injury1
Cataract1
Chronic Kidney Disease1

Age at onset

Adult1
Elderly1

Reporter sex

0 reports

Serious outcomes

Death2
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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

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) — 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 Nnodum Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nnodum Pharmaceuticals 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.
← 63044-0030-60 · Nnodum 63069-0052-14 · Penn →
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.