NDC 0003-0857

SPRYCEL

Dasatinib

SPRYCEL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Dasatinib.

Product ID0003-0857_08c1dd2b-39d5-4adc-96b2-2985fdc6c142
NDC0003-0857
Product TypeHuman Prescription Drug
Proprietary NameSPRYCEL
Generic NameDasatinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-10-28
Marketing CategoryNDA / NDA
Application NumberNDA021986
Labeler NameE.R. Squibb & Sons, L.L.C.
Substance NameDASATINIB
Active Ingredient Strength140 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0003-0857-22

1 BOTTLE in 1 CARTON (0003-0857-22) > 30 TABLET in 1 BOTTLE
Marketing Start Date2010-10-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-0857-22 [00003085722]

SPRYCEL TABLET
Marketing CategoryNDA
Application NumberNDA021986
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-28

Drug Details

Active Ingredients

IngredientStrength
DASATINIB140 mg/1

OpenFDA Data

SPL SET ID:4764f37b-c9e6-4ede-bcc2-8a03b7c521df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 643175
  • 1045404
  • 643177
  • 1045406
  • 643173
  • 1045402
  • 799047
  • 1045408
  • 643105
  • 643107
  • 799830
  • 643109
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]

    NDC Crossover Matching brand name "SPRYCEL" or generic name "Dasatinib"

    NDCBrand NameGeneric Name
    0003-0524SPRYCELdasatinib
    0003-0527SPRYCELdasatinib
    0003-0528SPRYCELdasatinib
    0003-0852SPRYCELdasatinib
    0003-0855SPRYCELdasatinib
    0003-0857SPRYCELdasatinib

    Trademark Results [SPRYCEL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SPRYCEL
    SPRYCEL
    78813186 3357619 Live/Registered
    Bristol-Myers Squibb Company
    2006-02-13
    SPRYCEL
    SPRYCEL
    78140234 3114787 Live/Registered
    Bristol-Myers Squibb Company
    2002-07-01
    SPRYCEL
    SPRYCEL
    77941220 3845228 Live/Registered
    Bristol-Myers Squibb Company
    2010-02-22
    SPRYCEL
    SPRYCEL
    77284740 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2007-09-20

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