NDC 68382-913

Erlotinib

Erlotinib

Erlotinib is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Erlotinib Hydrochloride.

Product ID68382-913_e715a711-283a-4662-8df0-d3b86ac5a042
NDC68382-913
Product TypeHuman Prescription Drug
Proprietary NameErlotinib
Generic NameErlotinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA213065
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameERLOTINIB HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-913-06

30 TABLET in 1 BOTTLE (68382-913-06)
Marketing Start Date2020-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-913-84 [68382091384]

Erlotinib TABLET
Marketing CategoryANDA
Application NumberANDA213065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 68382-913-16 [68382091316]

Erlotinib TABLET
Marketing CategoryANDA
Application NumberANDA213065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 68382-913-30 [68382091330]

Erlotinib TABLET
Marketing CategoryANDA
Application NumberANDA213065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 68382-913-06 [68382091306]

Erlotinib TABLET
Marketing CategoryANDA
Application NumberANDA213065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:c35e019d-ec34-4e61-9400-a7ae7913e025
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 603203
  • 603208
  • 603206
  • UPC Code
  • 0368382915061
  • 0368382913067
  • 0368382914064
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0093-7662ErlotinibErlotinib
    0093-7663ErlotinibErlotinib
    0093-7664ErlotinibErlotinib
    51991-890ErlotinibErlotinib Hydrochloride
    51991-891ErlotinibErlotinib Hydrochloride
    51991-892ErlotinibErlotinib Hydrochloride
    59651-530ErlotinibErlotinib
    59651-531ErlotinibErlotinib
    59651-532ErlotinibErlotinib
    59923-725ErlotinibErlotinib
    59923-726ErlotinibErlotinib
    59923-727ErlotinibErlotinib
    63304-095ErlotinibErlotinib
    63304-096ErlotinibErlotinib
    63304-135ErlotinibErlotinib
    68382-913ErlotinibErlotinib
    68382-914ErlotinibErlotinib
    68382-915ErlotinibErlotinib
    70771-1521ErlotinibErlotinib
    70771-1522ErlotinibErlotinib
    70771-1523ErlotinibErlotinib
    72485-217ErlotinibErlotinib hydrochloride
    72485-218ErlotinibErlotinib hydrochloride
    72485-219ErlotinibErlotinib hydrochloride

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