Tricon

Nnodum Pharmaceuticals
Human Prescription Drug
NDC 63044-635

Tricon is a human prescription drug labeled by 'Nnodum Pharmaceuticals'. National Drug Code (NDC) number for Tricon is 63044-635. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Tricon drug includes Ascorbic Acid - 75 mg/1 Cyanocobalamin - 15 ug/1 Ferrous Fumarate - 110 mg/1 Folic Acid - .5 mg/1 . The currest status of Tricon drug is Active.

Drug Information:

Drug NDC:	63044-635
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Tricon
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Tricon
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Nnodum Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ASCORBIC ACID - 75 mg/1 CYANOCOBALAMIN - 15 ug/1 FERROUS FUMARATE - 110 mg/1 FOLIC ACID - .5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	20 May, 2005
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	13 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Nnodum Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	999799
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0363044635011
UPC stands for Universal Product Code.
NUI:	N0000193618 M0001797 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	PQ6CK8PD0R P6YC3EG204 R5L488RY0Q 935E97BOY8
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Vitamin C [EPC] Vitamin B12 [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Ascorbic Acid [CS] Vitamin B 12 [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Ascorbic Acid [CS] Vitamin B 12 [CS] Vitamin B12 [EPC] Vitamin C [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
63044-635-10	10 BLISTER PACK in 1 BOX (63044-635-10) / 10 CAPSULE in 1 BLISTER PACK	20 May, 2005	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Tricon

Capsule
Nnodum Pharmaceuticals
NDC: 63044-635

Product Elements:

Tricon tricon cyanocobalamin cyanocobalamin ferrous fumarate ferrous cation ascorbic acid ascorbic acid folic acid folic acid citric acid monohydrate d&c yellow no. 10 ethylcellulose, unspecified fd&c blue no. 1 gelatin lecithin, soybean magnesium stearate silicon dioxide sodium benzoate sodium citrate sorbic acid starch, corn titanium dioxide opaque brown n635

Indications and Usage:

Indications and usage triconâ¢ 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.

General 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.

Dosage and Administration:

Dosage and administration one capsule twice a day. (two capsules daily produce a standard response in the average uncomplicated case of pernicious anemia.)

Contraindications:

Contraindications hemochromatosis and hemosiderosis are contraindications to iron therapy.

Adverse Reactions:

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.

Use in Pregnancy:

Pregnancy teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with triconâ¢ capsules. it is also not known whether triconâ¢ capsules can cause fetal harm when administered to pregnant women or can affect reproduction capacity. triconâ¢ capsules should be given to pregnant women only if clearly needed.

Pediatric Use:

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

Geriatric Use:

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:

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.

Description:

Description each triconâ¢ 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg 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.

Clinical Pharmacology:

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 p Read more...

ernicious anemia. the liver-stomach concetrate with intrinsic factor and the vitamin b12 contained in two triconâ¢ capsules provide 1Â½ 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 triconâ¢ (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:

How supplied triconâ¢ capsules are opaque brown ndc 63044-0635-10 unit dose packs containing 10 capsules per card. 100 capsules. storage: store at controlled room temperature 25Â°c (77Â°f); excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). [see usp controlled room temperature. manufactured for nnodum pharmaceuticals by contract pharmacal corporation 135 adams avenue hauppauge, new york 11788

Package Label Principal Display Panel:

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

Comments/ Reviews:

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