NDC 72485-205

Capecitabine 500mg

Capecitabine

Capecitabine 500mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is Capecitabine.

• Product ID: 72485-205_400dd42e-c53f-40ae-90df-c09c343046df
• NDC: 72485-205
• Product Type: Human Prescription Drug
• Proprietary Name: Capecitabine 500mg
• Generic Name: Capecitabine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207456
• Labeler Name: Armas Pharmaceuticals Inc.
• Substance Name: CAPECITABINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72485-205-12

1 BOTTLE in 1 CARTON (72485-205-12) > 120 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72485-205-12 [72485020512]

Capecitabine 500mg TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
CAPECITABINE	500 mg/1

OpenFDA Data

• SPL SET ID: f050d16c-ab76-489d-b92c-8c155b4e3f7c
• Manufacturer:
  • Armas Pharmaceuticals Inc.
• UNII:
  • 6804DJ8Z9U
• RxNorm Concept Unique ID - RxCUI:
  • 200328
• UPC Code:
  • 0372485205127

Pharmacological Class

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

NDC Crossover Matching brand name "Capecitabine 500mg" or generic name "Capecitabine"

NDC	Brand Name	Generic Name
72485-205	Capecitabine 500mg	Capecitabine 500mg
72606-555	Capecitabine 500mg	Capecitabine 500mg
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
0004-1100	Xeloda	capecitabine
0004-1101	Xeloda	capecitabine