Chromagen Capsule
NDC 75854-320

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 75854-320?
  5. Chromagen Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Chromagen (ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor) is a UNAPPROVED DRUG OTHER-approved product labeled by Avion Pharmaceuticals, Llc. This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. It is supplied as a blue capsule for oral administration. This product entry covers the primary NDC 75854-320 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
75854-320
Proprietary Name:
Chromagen
Non-Proprietary Name: [1]
Ferrous Asparto Glycinate, Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Intrinsic Factor
Substance Name: [2]
Ascorbic Acid; Cyanocobalamin; Ferrous Asparto Glycinate; Ferrous Fumarate; Folic Acid; Intrinsic Factor; Levomefolic Acid; Zinc
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Avion Pharmaceuticals, Llc
Labeler Code:
75854
Product Label ID:
13c5ed58-6333-498f-9ace-1049d7ae3552
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
01-10-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333 - PEARLESCENT DARK BLUE)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
CH75
Score:
1

Code Structure Chart

Product Details

What is NDC 75854-320?

The NDC code 75854-320 is assigned by the FDA to the product Chromagen. It is commonly known by its generic name, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor. This pharmaceutical product is labeled by Avion Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 75854-320-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins and iron are important building blocks of the body and help keep you in good health.

What are Active Ingredients of this product?

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.
  • ASCORBIC ACID 60 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • CYANOCOBALAMIN 10 ug/1
  • FERROUS ASPARTO GLYCINATE 25 mg/1
  • FERROUS FUMARATE 50 mg/1 - used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt
  • FOLIC ACID 250 ug/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.
  • INTRINSIC FACTOR 100 mg/1 - A glycoprotein secreted by the cells of the GASTRIC GLANDS that is required for the absorption of VITAMIN B 12 (cyanocobalamin). Deficiency of intrinsic factor leads to VITAMIN B 12 DEFICIENCY and ANEMIA, PERNICIOUS.
  • LEVOMEFOLIC ACID 750 ug/1
  • ZINC 12 mg/1 - A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with ANEMIA, short stature, HYPOGONADISM, impaired WOUND HEALING, and geophagia. It is known by the symbol Zn.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".