Centratex

Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous

Centurion Labs, Llc
Human Prescription Drug
NDC 23359-100

Centratex also known as Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous is a human prescription drug labeled by 'Centurion Labs, Llc'. National Drug Code (NDC) number for Centratex is 23359-100. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Centratex drug includes Calcium Pantothenate - 10 mg/1 Cupric Sulfate Anhydrous - .8 mg/1 Cyanocobalamin - 15 ug/1 Folic Acid - 1 mg/1 Iron - 106 mg/1 Magnesium Sulfate, Unspecified - 6.9 mg/1 Manganese Sulfate - 1.3 mg/1 Niacinamide - 30 mg/1 Pyridoxine Hydrochloride - 5 mg/1 Riboflavin - 6 mg/1 and more. The currest status of Centratex drug is Active.

Drug Information:

Drug NDC:	23359-100
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:	Centratex
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:	Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Centurion Labs, Llc
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:	CALCIUM PANTOTHENATE - 10 mg/1 CUPRIC SULFATE ANHYDROUS - .8 mg/1 CYANOCOBALAMIN - 15 ug/1 FOLIC ACID - 1 mg/1 IRON - 106 mg/1 MAGNESIUM SULFATE, UNSPECIFIED - 6.9 mg/1 MANGANESE SULFATE - 1.3 mg/1 NIACINAMIDE - 30 mg/1 PYRIDOXINE HYDROCHLORIDE - 5 mg/1 RIBOFLAVIN - 6 mg/1 Load more... SODIUM ASCORBATE - 200 mg/1 THIAMINE MONONITRATE - 10 mg/1 ZINC SULFATE - 18.2 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:	14 Jun, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Dec, 2025
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:	Centurion Labs, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	568ET80C3D KUW2Q3U1VV P6YC3EG204 935E97BOY8 E1UOL152H7 DE08037SAB W00LYS4T26 25X51I8RD4 68Y4CF58BV TLM2976OFR Load more... S033EH8359 8K0I04919X 89DS0H96TB
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 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:	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:	Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Blood Coagulation Factor [EPC] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Copper Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Magnetic Resonance Contrast Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] Vitamin B6 Analog [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
23359-100-10	100 CAPSULE in 1 BOTTLE (23359-100-10)	14 Jun, 2009	N/A	No
23359-100-30	30 CAPSULE in 1 BOTTLE (23359-100-30)	14 Jun, 2009	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

Centratex

Iron & more..

Capsule
Centurion Labs, LLC
NDC: 23359-100

Product Elements:

Centratex iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, niacinamide, calcium pantothenate, zinc sulfate, magnesium sulfate, manganese sulfate, and cupric sulfate anhydrous cellulose, microcrystalline silicon dioxide magnesium stearate gelatin iron iron sodium ascorbate ascorbic acid thiamine mononitrate thiamine ion thiamine riboflavin riboflavin pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin niacinamide niacinamide calcium pantothenate calcium cation zinc sulfate zinc cation magnesium sulfate, unspecified magnesium cation manganese sulfate manganese cation (2+) cupric sulfate anhydrous cupric cation clear with tan speckled powder

Indications and Usage:

Indications for the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. also for treatment of conditions where iron and vitamin c deficiency occur together, along with a poor intake or increased need for b-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.

Warnings:

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. iron is toxic and has been shown to cause severe reactions in children including death.

Warning folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b-12 is deficient.

General Precautions:

General folic acid in doses above 0.1 mg â 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Dosage and Administration:

Dosage and administration adults only: 1 capsule daily between meals, orally. not recommended in children.

Contraindications:

Contraindications centratex is contraindicated in patients with a known hypersensitivity to any of its ingredients. iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, and hemolytic anemias. folic acid may obscure signs and symptoms of pernicious anemia and is therefore a contraindication as well.

Adverse Reactions:

Adverse reaction allergic sensitizations have been reported following both oral and parenteral administration of folic acid. gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. although the absorption of iron is best when taken between meals, occasional g.i. disturbances may be controlled by giving centratex shortly after meals.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients has not been established.

Geriatric Use:

Geriatric use no clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. physicians should consider that elderly persons may have decreased hepatic, renal, or cardiac function.

Description:

Description active ingredients (each capsule) ferrous fumerate 106 mg(iron) vitamin c (sodium ascorbate) 200 mg vitamin b1 (thiamine mononitrate) 10 mg vitamin b2 (riboflavin) 6 mg vitamin b6 (pyridoxine hcl) 5 mg folic acid 1 mg vitamin b12 15 mcg niacinamide 30 mg pantothenic acid 10 mg zinc (zinc sulfate) 18.2 mg magnesium (magnesium sulfate) 6.9 mg copper (copper sulfate) 0.8 mg manganese (manganese sulfate) 1.3 mg inactive ingredients microcrystalline cellulose, silica, magnesium stearate, gelatin capsule

How Supplied:

How supplied centratex is supplied as a natural gelatin capsule with tan speckled powder. centratex is available in bottles of 100 (ndc 23359-100-10) and bottles of 30 (ndc 23359-100-30) dispense in a tight, light resistant container as defined in the usp/nf with a child resistant closure. store at room temperature between 15-30 degrees c (59-86 degrees f) keep in a cool, dry place.

Package Label Principal Display Panel:

Principal display panel - 100 capsule bottle label ndc 23359-100-10 centratex iron (ferrous fumarate, anhydrous) 106 mg vitamin c (sodium ascorbate) 200 mg vitamin b1 (thiamine mononitrate) 10 mg vitamin b2 (riboflavin) 6 mg vitamin b6 (pyridoxine hcl) 5 mg vitamin b12 (cyanocobalamin concentrate) 15 mcg folic acid 1 mg niacinamide (nicotinamide) 30 mg pantothenic acid (calcium pantothenate) 10 mg zinc (zinc sulfate) 18.2 mg magnesium (magnesium sulfate) 6.9 mg manganese (manganese sulfate) 1.3 mg copper (copper sulfate) 0.8 mg centurion labs rx only net contents: 100 capsules principal display panel - 100 capsule bottle label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.