NDC 0378-9045

Cystagon

Cysteamine Bitartrate

Cystagon is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Cysteamine Bitartrate.

Product ID0378-9045_263f8238-b6bd-42fa-b339-f27ede4026e2
NDC0378-9045
Product TypeHuman Prescription Drug
Proprietary NameCystagon
Generic NameCysteamine Bitartrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-04-11
Marketing End Date2030-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020392
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCYSTEAMINE BITARTRATE
Active Ingredient Strength150 mg/1
Pharm ClassesCystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-9045-05

500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)
Marketing Start Date2005-04-11
Marketing End Date2030-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9045-05 [00378904505]

Cystagon CAPSULE
Marketing CategoryNDA
Application NumberNDA020392
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-11

NDC 0378-9045-01 [00378904501]

Cystagon CAPSULE
Marketing CategoryNDA
Application NumberNDA020392
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-08-15
Marketing End Date2018-09-04

Drug Details

Active Ingredients

IngredientStrength
CYSTEAMINE BITARTRATE150 mg/1

OpenFDA Data

SPL SET ID:f495b76d-96c6-48e5-8fa3-30a4336628eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 209788
  • 209789
  • 309637
  • 309636
  • UPC Code
  • 0303789045058
  • Pharmacological Class

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

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

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

    Trademark Results [Cystagon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYSTAGON
    CYSTAGON
    74414870 1907806 Live/Registered
    Mylan Pharmaceuticals Inc.
    1993-07-21

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