NDC 0378-2512

Capecitabine

Capecitabine

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

• Product ID: 0378-2512_077c0c6c-e579-4f1d-bd1e-e6e687c31eb5
• NDC: 0378-2512
• Product Type: Human Prescription Drug
• Proprietary Name: Capecitabine
• Generic Name: Capecitabine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090943
• Labeler Name: Mylan 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: 2019-12-31

Packaging

NDC 0378-2512-78

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-78)

• Marketing Start Date: 2014-08-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-2512-78 [00378251278]

Capecitabine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090943
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-08

NDC 0378-2512-05 [00378251205]

Capecitabine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090943
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-08-08
• Marketing End Date: 2015-04-22

Drug Details

Active Ingredients

Ingredient	Strength
CAPECITABINE	500 mg/1

OpenFDA Data

• SPL SET ID: 03dd3301-e9ce-40af-84e1-7b70fc6557b0
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 6804DJ8Z9U
• RxNorm Concept Unique ID - RxCUI:
  • 200328
  • 200327

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
67877-458	Capecitabine	Capecitabine
67877-459	Capecitabine	Capecitabine
69097-949	Capecitabine	Capecitabine
69097-948	Capecitabine	Capecitabine
69539-019	Capecitabine	Capecitabine
69539-020	Capecitabine	Capecitabine
72205-006	Capecitabine	Capecitabine
72205-007	Capecitabine	Capecitabine
16714-468	CAPECITABINE	CAPECITABINE
16729-072	CAPECITABINE	CAPECITABINE
16729-073	CAPECITABINE	CAPECITABINE
42291-167	Capecitabine	Capecitabine
50268-154	Capecitabine	Capecitabine
51079-510	Capecitabine	Capecitabine
51407-095	Capecitabine	Capecitabine
51407-096	Capecitabine	Capecitabine
59651-204	Capecitabine	Capecitabine
59651-205	Capecitabine	Capecitabine
60687-149	Capecitabine	Capecitabine
63759-3000	Capecitabine	Capecitabine
63759-3001	Capecitabine	Capecitabine
64980-277	Capecitabine	Capecitabine
64980-276	Capecitabine	Capecitabine
65162-844	Capecitabine	Capecitabine
65162-843	Capecitabine	Capecitabine
0004-1100	Xeloda	capecitabine
0004-1101	Xeloda	capecitabine