NDC 53808-0411

Xeloda

Capecitabine

Xeloda is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Capecitabine.

• Product ID: 53808-0411_15601703-7442-48f3-89f4-44fef66b7514
• NDC: 53808-0411
• Product Type: Human Prescription Drug
• Proprietary Name: Xeloda
• Generic Name: Capecitabine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA020896
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: CAPECITABINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53808-0411-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0411-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0411-1 [53808041101]

Xeloda TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020896
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
CAPECITABINE	500 mg/1

OpenFDA Data

• SPL SET ID: a732b303-9bbd-42ba-a7c5-61c21629ba93
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 6804DJ8Z9U
• RxNorm Concept Unique ID - RxCUI:
  • 200328
  • 213293
• UPC Code:
  • 0300041101507

Pharmacological Class

• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Xeloda" or generic name "Capecitabine"

NDC	Brand Name	Generic Name
0004-1100	Xeloda	capecitabine
0004-1101	Xeloda	capecitabine
53808-0411	Xeloda	Xeloda
0054-0271	Capecitabine	Capecitabine
0054-0272	Capecitabine	Capecitabine
0093-7473	Capecitabine	Capecitabine
0093-7474	Capecitabine	Capecitabine
0378-2511	Capecitabine	capecitabine
0378-2512	Capecitabine	capecitabine
16714-467	CAPECITABINE	CAPECITABINE