NDC 69539-019

Capecitabine

Capecitabine

Capecitabine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Capecitabine.

• Product ID: 69539-019_03289f80-d73d-48c6-b3b9-938b9c45edf3
• NDC: 69539-019
• Product Type: Human Prescription Drug
• Proprietary Name: Capecitabine
• Generic Name: Capecitabine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209365
• Labeler Name: MSN LABORATORIES PRIVATE LIMITED
• Substance Name: CAPECITABINE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 69539-019-60

60 TABLET, FILM COATED in 1 BOTTLE (69539-019-60)

• Marketing Start Date: 2018-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69539-019-99 [69539001999]

Capecitabine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209365
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-02

NDC 69539-019-60 [69539001960]

Capecitabine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209365
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-02

Drug Details

Active Ingredients

Ingredient	Strength
CAPECITABINE	150 mg/1

OpenFDA Data

• SPL SET ID: 21f69a72-869c-46bc-be6f-f0f37e966af8
• Manufacturer:
  • MSN LABORATORIES PRIVATE LIMITED
• 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