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  4. NDC Product Code: 61474-4296 Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate

NDC 61474-4296 Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate

Capsule, Liquid Filled - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 61474-4296?
  4. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
61474-4296
Proprietary Name:
Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate
Non-Proprietary Name: [1]
Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate
Substance Name: [2]
.alpha.-tocopherol Acetate, Dl-; Calcium Citrate; Cholecalciferol; Doconexent; Ferrous Fumarate; Folic Acid; Iron Pentacarbonyl; Pyridoxine Hydrochloride
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Labeler Name: [5]
Catalent Ontario Limited
Labeler Code:
61474
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
09-29-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure:
Code Navigator:

Product Packages

NDC Code 61474-4296-1

Package Description: 2 BAG in 1 CARTON / 4000 CAPSULE, LIQUID FILLED in 1 BAG

Product Details

What is NDC 61474-4296?

The NDC code 61474-4296 is assigned by the FDA to the UNFINISHED product Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate which is drug for further processing product labeled by Catalent Ontario Limited. The generic name of Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate is doconexent, calcium citrate, pyridoxine hydrochloride, ferrous fumarate, carbonyl iron, folic acid, cholecalciferol, dl-alpha tocopheryl acetate. The product's dosage form is capsule, liquid filled. The product is distributed in a single package with assigned NDC code 61474-4296-1 2 bag in 1 carton / 4000 capsule, liquid filled in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are Doconexent, Calcium Citrate, Pyridoxine Hydrochloride, Ferrous Fumarate, Carbonyl Iron, Folic Acid, Cholecalciferol, Dl-alpha Tocopheryl Acetate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU]/1
  • CALCIUM CITRATE 62.06 mg/1 - A colorless crystalline or white powdery organic, tricarboxylic acid occurring in plants, especially citrus fruits, and used as a flavoring agent, as an antioxidant in foods, and as a sequestrating agent. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
  • CHOLECALCIFEROL 200 [iU]/1 - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • DOCONEXENT 200 mg/1
  • FERROUS FUMARATE 2 mg/1
  • FOLIC ACID 1 mg/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • IRON PENTACARBONYL 25 mg/1
  • PYRIDOXINE HYDROCHLORIDE 12.5 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.