NDC 42292-053

Erlotinib Hydrochloride

Erlotinib Hydrochloride

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

Product ID42292-053_8a8655b8-0a44-082b-e053-2995a90aae63
NDC42292-053
Product TypeHuman Prescription Drug
Proprietary NameErlotinib Hydrochloride
Generic NameErlotinib Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA091002
Labeler NameMylan Institutional Inc.
Substance NameERLOTINIB
Active Ingredient Strength150 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42292-053-05

20 BLISTER PACK in 1 CARTON (42292-053-05) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-053-01)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42292-053-01 [42292005301]

Erlotinib Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091002
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-28

NDC 42292-053-05 [42292005305]

Erlotinib Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091002
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-28

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB150 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
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
69539-090Erlotinib HydrochlorideErlotinib Hydrochloride
69539-091Erlotinib HydrochlorideErlotinib Hydrochloride
69539-092Erlotinib HydrochlorideErlotinib Hydrochloride
72205-080Erlotinib HydrochlorideErlotinib Hydrochloride
72205-081Erlotinib HydrochlorideErlotinib Hydrochloride
72205-082Erlotinib HydrochlorideErlotinib Hydrochloride
51991-890ErlotinibErlotinib Hydrochloride
51991-891ErlotinibErlotinib Hydrochloride
51991-892ErlotinibErlotinib Hydrochloride
72485-217ErlotinibErlotinib hydrochloride
72485-218ErlotinibErlotinib hydrochloride
72485-219ErlotinibErlotinib hydrochloride
50242-062TARCEVAerlotinib hydrochloride
50242-063TARCEVAerlotinib hydrochloride
50242-064TARCEVAerlotinib hydrochloride
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.