NDC 59651-205

Capecitabine

Capecitabine

Capecitabine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Capecitabine.

Product ID59651-205_0c445684-17a6-49c7-ad72-9258ae80d78e
NDC59651-205
Product TypeHuman Prescription Drug
Proprietary NameCapecitabine
Generic NameCapecitabine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-17
Marketing CategoryANDA / ANDA
Application NumberANDA210604
Labeler NameAurobindo Pharma Limited
Substance NameCAPECITABINE
Active Ingredient Strength500 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59651-205-08

120 TABLET in 1 BOTTLE (59651-205-08)
Marketing Start Date2018-04-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59651-205-10 [59651020510]

Capecitabine TABLET
Marketing CategoryANDA
Application NumberANDA210604
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-17

NDC 59651-205-08 [59651020508]

Capecitabine TABLET
Marketing CategoryANDA
Application NumberANDA210604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-17

Drug Details

Active Ingredients

IngredientStrength
CAPECITABINE500 mg/1

OpenFDA Data

SPL SET ID:56441153-a1e5-4fdc-96d6-f21baa6b5fbe
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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