Label: NORCALPHOS injection, solution

  • Category: PRESCRIPTION ANIMAL 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 February 8, 2023

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  • VETERINARY INDICATIONS

    Parenteral Solution

    FOR ANIMAL USE ONLY

  • Contraindications

    Do not administer intraperitoneally to horses.

  • Indications

    For intravenous use in milk fever, and in calcium, phosphorus, magnesium and glucose deficiency in animals.

  • Note

    Intravenous administration is always preferable. If used subcutaneously, always distribute dose in several places and massage to facilitate absorption.

  • Dosage & Administration

    Cattle - 500 mL.

    For milk fever prophylaxis, give 200-500 mL at time of calving.

    Horses - 250-500 mL

    Sheep - 50-125 mL

    Repeat in 2 to 6 hours if needed.

    This product contains no preservative. Unused portion remaining in bottle must be discarded.

  • Caution

    Large doses administered intravenously may have toxic action on heart if the blood level of calcium is raised excessively. Doses should be carefully regulated according to severitity of hypocalcemia and injected slowly so that administration may be stopped if toxic action becomes evident.

  • WARNINGS AND PRECAUTIONS

    KEEP OUT OF REACH OF CHILDREN

  • CAUTION:

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • CONTAINS

    Calcium borogluconate, dextrose, magnesium borogluconate, calcium hypophosphite and base.

    Total calcium chemically equivalent to calcium borogluconate .......................................... 26.0% w/v

    Dextrose • H2O ......................................................................................................... 15.0% w/v

    Magnesium Borogluconate ............................................................................................ 6.0% w/v

    Total phosphorus in amounts chemically equivalent to elemental phosphorus ...................... 0.5% w/v

  • STORAGE AND HANDLING

    Store between 15°C-30°C (59°F-86°F).

  • PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.

    Grand Island, NE 68801 USA

    18-811

    RMS 92-340

    NDC# 65207-811-50

    Net Contents:

    500 mL (16.91 fl oz)

    Assembled in USA

    Lot No.

    Exp. Date

  • PRINCIPAL DISPLAY PANEL

    500 mL label

  • INGREDIENTS AND APPEARANCE
    NORCALPHOS 
    norcalphos injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-811
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Borogluconate (UNII: 6915G2PQI0) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION26 g  in 100 mL
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE15 g  in 100 mL
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE6 g  in 100 mL
    Phosphorus (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) Phosphorus0.5 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65207-811-50500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/22/2019
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture, analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruibang Laboratories544807456api manufacture