NDC 75987-145

PROCYSBI

Cysteamine Bitartrate

PROCYSBI is a Oral Granule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Cysteamine Bitartrate.

Product ID75987-145_03837d9e-aee3-46e9-a893-b05a24397170
NDC75987-145
Product TypeHuman Prescription Drug
Proprietary NamePROCYSBI
Generic NameCysteamine Bitartrate
Dosage FormGranule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-02-14
Marketing CategoryNDA / NDA
Application NumberNDA213491
Labeler NameHorizon Therapeutics USA, Inc.
Substance NameCYSTEAMINE BITARTRATE
Active Ingredient Strength300 mg/1
Pharm ClassesCystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 75987-145-13

60 PACKET in 1 CARTON (75987-145-13) > 1 GRANULE, DELAYED RELEASE in 1 PACKET
Marketing Start Date2020-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-145-13 [75987014513]

PROCYSBI GRANULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA213491
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-14

NDC 75987-145-14 [75987014514]

PROCYSBI GRANULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA213491
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-14

Drug Details

Active Ingredients

IngredientStrength
CYSTEAMINE BITARTRATE300 mg/1

OpenFDA Data

SPL SET ID:d3a3ec28-f746-463a-bb92-3bc8826db09e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1421473
  • 1421467
  • 1421477
  • 1421475
  • 2284515
  • 2284514
  • 2284516
  • 2284510
  • UPC Code
  • 0375987101089
  • Pharmacological Class

    • Cystine Depleting Agent [EPC]
    • Cystine Disulfide Reduction [MoA]

    NDC Crossover Matching brand name "PROCYSBI" or generic name "Cysteamine Bitartrate"

    NDCBrand NameGeneric Name
    75987-100PROCYSBICysteamine bitartrate
    75987-101PROCYSBICysteamine bitartrate
    75987-140PROCYSBICysteamine bitartrate
    75987-145PROCYSBICysteamine bitartrate
    0378-9040Cystagoncysteamine bitartrate
    0378-9045Cystagoncysteamine bitartrate

    Trademark Results [PROCYSBI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCYSBI
    PROCYSBI
    85550512 4407821 Live/Registered
    HORIZON ORPHAN LLC
    2012-02-23

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