NDC 51991-891

Erlotinib

Erlotinib Hydrochloride

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

Product ID51991-891_10283023-b2e0-478f-823c-cf137dae00bd
NDC51991-891
Product TypeHuman Prescription Drug
Proprietary NameErlotinib
Generic NameErlotinib Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA208488
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameERLOTINIB HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51991-891-33

30 TABLET, FILM COATED in 1 BOTTLE (51991-891-33)
Marketing Start Date2019-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-891-33 [51991089133]

Erlotinib TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-05

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB HYDROCHLORIDE100 mg/1

Pharmacological Class

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

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

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
72485-217ErlotinibErlotinib
72485-219ErlotinibErlotinib
72485-218ErlotinibErlotinib
68382-915ErlotinibErlotinib
68382-914ErlotinibErlotinib
70771-1521ErlotinibErlotinib
70771-1523ErlotinibErlotinib
70771-1522ErlotinibErlotinib
0378-7131Erlotinib Hydrochlorideerlotinib hydrochloride
0378-7132Erlotinib Hydrochlorideerlotinib hydrochloride
0378-7133Erlotinib Hydrochlorideerlotinib hydrochloride
42292-051Erlotinib Hydrochlorideerlotinib hydrochloride
42292-052Erlotinib Hydrochlorideerlotinib hydrochloride
42292-053Erlotinib Hydrochlorideerlotinib hydrochloride
46708-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
46708-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
46708-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-565ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-566ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
62332-567ERLOTINIB HYDROCHLORIDEERLOTINIB HYDROCHLORIDE
50242-062TARCEVAerlotinib hydrochloride
50242-063TARCEVAerlotinib hydrochloride
50242-064TARCEVAerlotinib hydrochloride
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