Label: NEPHRON FA- mineral/vitamin supplement tablet, coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 7, 2014

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  • Description

    Nephron FA is a prescription folic acid supplement with additional nutrients for kidney dialysis patients.  Nephron FA is an elongated, white, film coated tablet imprinted with NT and scored on one side, plain on the other.

  • Precaution

    Folic Acid may obscure pernicious anemia or produce remission while neurologic progress may continue.

  • Suggested Dosage

    One tablet daily taken away from meals, or as directed by the physician.

  • Package Label/Principal Display Panel

    59528-4456-1

    Rx Only

    Nephron FA

    Vitamin/Mineral Supplement

    100 tablets

    Nephron FA label

  • INGREDIENTS AND APPEARANCE
    NEPHRON FA 
    mineral/vitamin supplement tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59528-4456
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRON (UNII: E1UOL152H7) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION66 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID40 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    Biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) Biotin.3 mg
    COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN.006 mg
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapecapsuleSize19mm
    FlavorImprint Code NT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59528-4456-1100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/1992
    Labeler - Nephro-Tech, Inc. (878520485)
    Registrant - Nephro-Tech, Inc. (878520485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma160356114manufacture(59528-4456)