NDC 0378-7132

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 Pharmaceuticals Inc.. The primary component is Erlotinib.

Product ID0378-7132_a0582690-5b89-4f2f-bb9e-7591466c24d1
NDC0378-7132
Product TypeHuman Prescription Drug
Proprietary NameErlotinib Hydrochloride
Generic NameErlotinib Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA091002
Labeler NameMylan Pharmaceuticals Inc.
Substance NameERLOTINIB
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7132-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7132-93)
Marketing Start Date2019-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7132-93 [00378713293]

Erlotinib Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091002
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-09

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB100 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
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