NDC 75854-321 Niferex
Ferrous Asparto Glycinate,Iron,Ascorbic Acid,Folic Acid,Cyanocobalamin,Zinc,Succinic - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 75854 - Avion Pharmaceuticals, Llc
- 75854-321 - Niferex
Product Characteristics
Product Packages
NDC Code 75854-321-30
Package Description: 30 TABLET in 1 BOTTLE
Product Details
What is NDC 75854-321?
What are the uses for Niferex?
What are Niferex Active Ingredients?
- 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 25 ug/1
- FERROUS ASPARTO GLYCINATE 50 mg/1
- 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.
- IRON DEXTRAN 100 mg/1
- LEVOMEFOLIC ACID 750 ug/1
- SUCCINIC ACID 50 mg/1 - A water-soluble, colorless crystal with an acid taste that is used as a chemical intermediate, in medicine, the manufacture of lacquers, and to make perfume esters. It is also used in foods as a sequestrant, buffer, and a neutralizing agent. (Hawley's Condensed Chemical Dictionary, 12th ed, p1099; McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1851)
- ZINC 15 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 Niferex UNII Codes?
The UNII codes for the active ingredients in this product are:
- FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L)
- FERROUS CATION (UNII: GW89581OWR) (Active Moiety)
- IRON DEXTRAN (UNII: 95HR524N2M)
- FERRIC CATION (UNII: 91O4LML611) (Active Moiety)
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- ASCORBIC ACID (UNII: PQ6CK8PD0R) (Active Moiety)
- LEVOMEFOLIC ACID (UNII: 8S95DH25XC)
- LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (Active Moiety)
- FOLIC ACID (UNII: 935E97BOY8)
- FOLIC ACID (UNII: 935E97BOY8) (Active Moiety)
- CYANOCOBALAMIN (UNII: P6YC3EG204)
- CYANOCOBALAMIN (UNII: P6YC3EG204) (Active Moiety)
- ZINC (UNII: J41CSQ7QDS)
- ZINC (UNII: J41CSQ7QDS) (Active Moiety)
- SUCCINIC ACID (UNII: AB6MNQ6J6L)
- SUCCINIC ACID (UNII: AB6MNQ6J6L) (Active Moiety)
- INTRINSIC FACTOR (UNII: 70BT6OQT2Q)
- INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (Active Moiety)
Which are Niferex Inactive Ingredients 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:
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Which are the Pharmacologic Classes for Niferex?
- Ascorbic Acid - [CS]
- Folate Analog - [EPC] (Established Pharmacologic Class)
- Folic Acid - [CS]
- Iron - [CS]
- Parenteral Iron Replacement - [EPC] (Established Pharmacologic Class)
- Phosphate Binder - [EPC] (Established Pharmacologic Class)
- Phosphate Chelating Activity - [MoA] (Mechanism of Action)
- Vitamin B 12 - [CS]
- Vitamin B12 - [EPC] (Established Pharmacologic Class)
- Vitamin C - [EPC] (Established Pharmacologic Class)
* Please review the disclaimer below.
[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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[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".