NDC 54092-063

Agrylin

Anagrelide Hydrochloride

Agrylin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Anagrelide Hydrochloride.

Product ID54092-063_2e8a557f-0338-47ff-9ba8-ff4bbf193d1b
NDC54092-063
Product TypeHuman Prescription Drug
Proprietary NameAgrylin
Generic NameAnagrelide Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1997-03-14
Marketing CategoryNDA / NDA
Application NumberNDA020333
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameANAGRELIDE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDecreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 54092-063-01

100 CAPSULE in 1 BOTTLE (54092-063-01)
Marketing Start Date1997-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-063-01 [54092006301]

Agrylin CAPSULE
Marketing CategoryNDA
Application NumberNDA020333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-03-14

Drug Details

Active Ingredients

IngredientStrength
ANAGRELIDE HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:cb960074-99c1-4a73-941f-f0644a7ec219
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597857
  • 597850
  • UPC Code
  • 0354092063017
  • Pharmacological Class

    • Decreased Platelet Production [PE]
    • Platelet-reducing Agent [EPC]
    • Phosphodiesterase 3 Inhibitors [MoA]

    NDC Crossover Matching brand name "Agrylin" or generic name "Anagrelide Hydrochloride"

    NDCBrand NameGeneric Name
    54092-063Agrylinanagrelide hydrochloride
    0172-5240Anagrelide HydrochlorideAnagrelide Hydrochloride
    0172-5241Anagrelide HydrochlorideAnagrelide Hydrochloride
    68151-2959Anagrelide HydrochlorideAnagrelide Hydrochloride

    Trademark Results [Agrylin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AGRYLIN
    AGRYLIN
    78609806 3119751 Live/Registered
    Shire LLC
    2005-04-15
    AGRYLIN
    AGRYLIN
    75195604 2160991 Dead/Cancelled
    SHIRE LLC
    1996-11-12

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