NDC 63304-095

Erlotinib

Erlotinib

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

Product ID63304-095_c160713b-c06f-49b4-80ea-fc1afb030b81
NDC63304-095
Product TypeHuman Prescription Drug
Proprietary NameErlotinib
Generic NameErlotinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA210300
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameERLOTINIB
Active Ingredient Strength25 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63304-095-11

3 BLISTER PACK in 1 CARTON (63304-095-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-095-31)
Marketing Start Date2019-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-095-31 [63304009531]

Erlotinib TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210300
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-05

NDC 63304-095-30 [63304009530]

Erlotinib TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210300
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-05

NDC 63304-095-11 [63304009511]

Erlotinib TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210300
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-05

Drug Details

Active Ingredients

IngredientStrength
ERLOTINIB25 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"

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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