NDC 0004-1101

Xeloda

Capecitabine

Xeloda is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Capecitabine.

• Product ID: 0004-1101_291d4df7-44eb-4bc6-a04e-e057cac12144
• NDC: 0004-1101
• Product Type: Human Prescription Drug
• Proprietary Name: Xeloda
• Generic Name: Capecitabine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA020896
• Labeler Name: Genentech, Inc.
• Substance Name: CAPECITABINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Nucleic Acid Sy
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0004-1101-50

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50)

• Marketing Start Date: 1998-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-1101-75 [00004110175]

Xeloda TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020896
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-04-30
• Marketing End Date: 2014-12-31

NDC 0004-1101-51 [00004110151]

Xeloda TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020896
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-03-05
• Marketing End Date: 2011-12-20

NDC 0004-1101-50 [00004110150]

Xeloda TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020896
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-04-30

Drug Details

Active Ingredients

Ingredient	Strength
CAPECITABINE	500 mg/1

OpenFDA Data

• SPL SET ID: a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 6804DJ8Z9U
• RxNorm Concept Unique ID - RxCUI:
  • 200328
  • 213293
  • 200327
  • 213292

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