NDC 70771-1521

Erlotinib

Erlotinib

Erlotinib is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Erlotinib Hydrochloride.

Product ID70771-1521_5624fa69-eae5-43bf-aa7e-379266edd77f
NDC70771-1521
Product TypeHuman Prescription Drug
Proprietary NameErlotinib
Generic NameErlotinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA213065
Labeler NameCadila Healthcare Limited
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 70771-1521-3

30 TABLET, FILM COATED in 1 BOTTLE (70771-1521-3)
Marketing Start Date2020-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1521-7 [70771152107]

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

NDC 70771-1521-2 [70771152102]

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

NDC 70771-1521-3 [70771152103]

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

NDC 70771-1521-9 [70771152109]

Erlotinib TABLET, FILM COATED
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:daaa1329-3a3f-439c-b13d-b301daa234d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 603203
  • 603208
  • 603206
  • 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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