NDC 59923-727

Erlotinib

Erlotinib

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

Product ID59923-727_a436687b-3fe8-386e-e053-2995a90a47da
NDC59923-727
Product TypeHuman Prescription Drug
Proprietary NameErlotinib
Generic NameErlotinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA211960
Labeler NameAreva Pharmaceuticals
Substance NameERLOTINIB HYDROCHLORIDE
Active Ingredient Strength150 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59923-727-30

1 BOTTLE in 1 BOX (59923-727-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59923-727-30 [59923072730]

Erlotinib TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211960
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB HYDROCHLORIDE150 mg/1

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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