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 ID0378-2512_077c0c6c-e579-4f1d-bd1e-e6e687c31eb5
NDC0378-2512
Product TypeHuman Prescription Drug
Proprietary NameCapecitabine
Generic NameCapecitabine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA090943
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCAPECITABINE
Active Ingredient Strength500 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-2512-78

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-78)
Marketing Start Date2014-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2512-78 [00378251278]

Capecitabine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090943
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-08

NDC 0378-2512-05 [00378251205]

Capecitabine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090943
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-08
Marketing End Date2015-04-22

Drug Details

Active Ingredients

IngredientStrength
CAPECITABINE500 mg/1

OpenFDA Data

SPL SET ID:03dd3301-e9ce-40af-84e1-7b70fc6557b0
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0054-0271CapecitabineCapecitabine
    0054-0272CapecitabineCapecitabine
    0093-7473CapecitabineCapecitabine
    0093-7474CapecitabineCapecitabine
    0378-2511Capecitabinecapecitabine
    0378-2512Capecitabinecapecitabine
    16714-467CAPECITABINECAPECITABINE
    67877-458CapecitabineCapecitabine
    67877-459CapecitabineCapecitabine
    69097-949CapecitabineCapecitabine
    69097-948CapecitabineCapecitabine
    69539-019CapecitabineCapecitabine
    69539-020CapecitabineCapecitabine
    72205-006CapecitabineCapecitabine
    72205-007CapecitabineCapecitabine
    16714-468CAPECITABINECAPECITABINE
    16729-072CAPECITABINECAPECITABINE
    16729-073CAPECITABINECAPECITABINE
    42291-167CapecitabineCapecitabine
    50268-154CapecitabineCapecitabine
    51079-510CapecitabineCapecitabine
    51407-095CapecitabineCapecitabine
    51407-096CapecitabineCapecitabine
    59651-204CapecitabineCapecitabine
    59651-205CapecitabineCapecitabine
    60687-149CapecitabineCapecitabine
    63759-3000CapecitabineCapecitabine
    63759-3001CapecitabineCapecitabine
    64980-277CapecitabineCapecitabine
    64980-276CapecitabineCapecitabine
    65162-844CapecitabineCapecitabine
    65162-843CapecitabineCapecitabine
    0004-1100Xelodacapecitabine
    0004-1101Xelodacapecitabine

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