NDC 0003-0852

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 ID: 0003-0852_08c1dd2b-39d5-4adc-96b2-2985fdc6c142
• NDC: 0003-0852
• Product Type: Human Prescription Drug
• Proprietary Name: SPRYCEL
• Generic Name: Dasatinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-05-30
• Marketing Category: NDA / NDA
• Application Number: NDA021986
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: DASATINIB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0003-0852-22

1 BOTTLE in 1 CARTON (0003-0852-22) > 30 TABLET in 1 BOTTLE

• Marketing Start Date: 2008-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-0852-22 [00003085222]

SPRYCEL TABLET

• Marketing Category: NDA
• Application Number: NDA021986
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-30

NDC 0003-0852-11 [00003085211]

SPRYCEL TABLET

• Marketing Category: NDA
• Application Number: NDA021986
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-06-03
• Marketing End Date: 2011-01-26

Drug Details

Active Ingredients

Ingredient	Strength
DASATINIB	100 mg/1

OpenFDA Data

• SPL SET ID: 4764f37b-c9e6-4ede-bcc2-8a03b7c521df
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • RBZ1571X5H
• 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"

NDC	Brand Name	Generic Name
0003-0524	SPRYCEL	dasatinib
0003-0527	SPRYCEL	dasatinib
0003-0528	SPRYCEL	dasatinib
0003-0852	SPRYCEL	dasatinib
0003-0855	SPRYCEL	dasatinib
0003-0857	SPRYCEL	dasatinib