Integra F Capsule
NDC 52747-711

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52747-711?
  5. Integra F Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Integra F (ferrous fumarate and polysacchride iron complex and folic acid) is a UNAPPROVED DRUG OTHER-approved product labeled by U.s. Pharmaceutical Corporation. This medication is typically used as a ascorbic acid [cs]. It is supplied as a red capsule for oral administration. This product entry covers the primary NDC 52747-711 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
52747-711
Proprietary Name:
Integra F
Non-Proprietary Name: [1]
Ferrous Fumarate And Polysacchride Iron Complex And Folic Acid
Substance Name: [2]
Ascorbic Acid; Ferrous Asparto Glycinate; Ferrous Fumarate; Folic Acid; Niacin
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]
U.s. Pharmaceutical Corporation
Labeler Code:
52747
Product Label ID:
025fee85-53a8-4161-a806-44fd95d0ca74
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]
04-27-2009
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326 - MAROON BODY AND CAP)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
INTEGRA;F;US
Score:
1

Code Structure Chart

Product Details

What is NDC 52747-711?

The NDC code 52747-711 is assigned by the FDA to the product Integra F. It is commonly known by its generic name, ferrous fumarate and polysacchride iron complex and folic acid. This pharmaceutical product is labeled by U.s. Pharmaceutical Corporation 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 2 different package configurations. The associated package NDC(s) include: 52747-711-30, 52747-711-60. 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?

INDICATIONS: Integra FTM is indicated for the treatment of iron deficiency anemia, and folate deficiency anemia. Integra FTM is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

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 40 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.
  • FERROUS ASPARTO GLYCINATE 62.5 mg/1
  • FERROUS FUMARATE 62.5 mg/1 - used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt
  • 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.
  • NIACIN 3 mg/1 - A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.

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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 999823 - ascorbic acid 40 MG / ferrous fumarate 191 MG / folic acid 1 MG / niacinamide 3 MG / polysaccharide iron complex 136 MG Oral Capsule
  • RxCUI: 999823 - vitamin C 40 MG / Ferrous fumarate 191 MG / folate 1 MG / Niacinamide 3 MG / Polysaccharide iron complex 136 MG Oral Capsule
  • RxCUI: 999823 - vit-C 40 MG / Ferrous fumarate 191 MG / folate 1 MG / Niacinamide 3 MG / Polysaccharide iron complex 136 MG Oral Capsule
  • RxCUI: 999826 - ascorbic acid 40 MG / ferrous fumarate 191 MG / folic acid 1 MG / niacinamide 3 MG / polysaccharide iron complex 136 MG Oral Capsule [Integra F]
  • RxCUI: 999826 - Integra F (ascorbic acid 40 MG / ferrous fumarate 191 MG (iron 62.5 MG) / folic acid 1 MG / vitamin B3 3 MG / polysaccharide iron complex 136 MG (iron 62.5 MG)) Oral Capsule

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".