Label: SYNAPRYN- tramadol hydrochloride

  • NDC Code(s): 70332-107-01
  • Packager: California Pharmaceuticals, LLC
  • 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 August 7, 2017

If you are a consumer or patient please visit this version.

  • Pharmacist Instructions For Preparation

    Pharmacist Instructions for Preparation

    1 Remove and Inspect the Contents of the Kit

    Ensure that the safety seals are present and intact on the tramadol hydrochloride glass vial, the cherry flavoring bottle, and the oral suspension bottle. If the seals are not intact, do not use the kit.

    2 Prepare for Combining

    Wear gloves and eye protection during the compounding operations. Remove the seals from the Cherry flavor bottle and the oral suspension bottle. Break the perforated seal and remove the cap from the tramadol hydrochloride bottle.

    3 Transfer the Oral Suspension Vehicle to the Tramadol Hydrochloride Bottle

    Uncap the oral suspension bottle. Pour a small amount of the oral suspension liquid (approximately one-third to one-half the volume of the tramadol hydrochloride bottle) into the tramadol hydrochloride bottle. Cap the tramadol bottle and shake well several times to dissolve the tramadol hydrochloride powder. Empty the dissolved contents back into the oral suspension bottle. Cap and shake well the oral suspension bottle. Repeat this step a minimum of 3 times. Visually ensure that all of the tramadol hydrochloride has been dissolved and transfered to the suspension bottle.

    4 Transfer the Oral Suspension Vehicle that now contains the suspended Tramadol Hydrochloride to the Cherry Flavoring Bottle

    Uncap the oral suspension bottle that now contains the suspended tramadol hydrochloride. Uncap the bottle that contains the cherry flavoring. Pour the entire contents of the oral suspension bottle into the cherry flavoring bottle. Shake vigorously by inverting the bottle repeatedly several times.

    5 Complete the Combining Process

    Press the oral syringe adaptor into the cherry flavor bottle suspension. Recap the flavor bottle suspension, which now contains the tramadol hydrochloride. Shake well by inverting repeatedly several times.

    6 Re-label the Resulting Final Suspension

    Label the resulting final suspension as required for prescription products. Ensure that the original cherry oral suspension vehicle label is removed or obscured since the original label is no longer accurate once the resulting final suspension is completed. The contents of the bottle need to be shaken well before taken as directed by the medical professional.

    Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the resulting final suspension between 15-30°C (59-86°F). The resulting final suspension is stable for up to eight weeks based upon the real-time and accelerated stability studies.

    An oral dispenser is provided in the kit and may be used to facilitate the accurate delivery of the suspension.

    U.S. Patents Pending

    Manufactured and repacked by:
    California Pharmaceuticals, LLC
    768 Calle Plano
    Camarillo, CA 93012

    CSCIV7 rev 0

    Calif CherrySusp - 107

    Calif OralSusp - 107

    Calif Instruct1 107

    Calif Istruct2 107

    Label

    Calif Tramadol 107

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  • Synapryn - 107 product label

    NDC 70332-107-01 For Prescription Compounding Only Rx only

    RapidPaq™ SYNAPRYN™ CIV

    (tramadol hydrochloride 11.4 mg/mL [equivalent to 10.0 mg/mL tramadol] Cherry oral suspension-kit)

    RapidPaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to the US FDA current Good Manufacturing Practice (cGMP).

    Description
    This kit contains active and inactive materials to prepare 500 mL of a tramadol hydrochloride cherry oral suspension containing 11.4 mg/mL tramadol hydrochloride [equivalent to 10.0 mg/mL tramadol]. This kit may only be used for prescription compounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specific needs of an individual patient.

    Contains:

    - 5.8 g tramadol hydrochloride USP [equivalent to 5.1 g tramadol]

    - 250 mL Cherry Flavor Vehicle (purified water, glycerin, cherry flavor, sorbitol, potassium sorbate, xanthan gum, sodium saccharin, sodium benzoate, sodium citric acid)

    - 250 mL Oral Suspension vehicle (purified water, potassium sorbate, sodium benzoate, citric acid)

    - Press in bottle adaptor

    - Oral dispenser

    - Insructions

    Calif Synapryn 107

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  • INGREDIENTS AND APPEARANCE
    SYNAPRYN 
    tramadol hydrochloride kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-107
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70332-107-01 1 in 1 KIT 05/01/2017
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL, GLASS 5.8 g
    Part 2 1 BOTTLE 250 mL
    Part 3 1 BOTTLE 250 mL
    Part 1 of 3
    TRAMADOL HYDROCHLORIDE 
    tramadol hydrochloride powder, for solution
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 5.8 g  in 5.8 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5.8 g in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2017
    Part 2 of 3
    SYNAPRYN VEHICLE 
    synapryn vehicle liquid
    Product Information
    Route of Administration ORAL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2017
    Part 3 of 3
    FLAVOR VEHICLE 
    flavor vehicle liquid
    Product Information
    Route of Administration ORAL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2017
    Labeler - California Pharmaceuticals, LLC (021420944)
    Registrant - California Pharmaceuticals, LLC (021420944)
    Establishment
    Name Address ID/FEI Business Operations
    California Pharmaceuticals, LLC 021420944 manufacture(70332-107) , relabel(70332-107) , repack(70332-107)
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