NDC 64811-400

Cystadane

Betaine

Cystadane is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Ropack Inc.. The primary component is Betaine.

Product ID64811-400_7c254f3d-2a1c-3b17-e053-2a91aa0aea34
NDC64811-400
Product TypeHuman Prescription Drug
Proprietary NameCystadane
Generic NameBetaine
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2017-04-13
Marketing CategoryNDA / NDA
Application NumberNDA020576
Labeler NameRopack Inc.
Substance NameBETAINE
Active Ingredient Strength1 g/g
Pharm ClassesMethylating Activity [MoA],Methylating Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64811-400-01

180 g in 1 BOTTLE (64811-400-01)
Marketing Start Date2017-04-13
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
BETAINE1 g/g

OpenFDA Data

SPL SET ID:65450ac0-7ced-7be4-e053-2991aa0a8c10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404539
  • 562847
  • UPC Code
  • 0352276400016
  • Pharmacological Class

    • Methylating Activity [MoA]
    • Methylating Agent [EPC]

    NDC Crossover Matching brand name "Cystadane" or generic name "Betaine"

    NDCBrand NameGeneric Name
    52276-400Cystadanebetaine
    52276-401Cystadanebetaine
    64811-400CystadaneBETAINE
    66621-4000Cystadanebetaine
    70993-0005ATONO2 Oxygen BabyBetaine
    0713-0352BetaineBetaine
    55792-002Betaine Anhydrous For Oral Solutionbetaine
    83071-020Dr.Jucre Rebirth Activating TonerBetaine

    Trademark Results [Cystadane]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYSTADANE
    CYSTADANE
    74609648 2055894 Live/Registered
    RECORDATI ORPHAN DRUGS
    1994-12-12

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