Erlotinib Hydrochloride

Product NDC
0378-7133
11-digit product format
003787133
Labeler code
0378
Product ID
0378-7133_c91e4788-c25a-4cf4-ab7f-192b73e8fa25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erlotinib hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA091002
Marketing category
ANDA
Marketing start
2019-05-09
Marketing end
2022-11-30
Substance
ERLOTINIB
Active strength
150 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7133-93EA - Each0378-71335cea5e4e-6135-4da3-ba25-2f3af1964c0312019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-7133-930037871339330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7133-93) 2019-05-090000-00-00NoNoCurrent