Erlotinib Hydrochloride

Product NDC
69539-090
11-digit product format
695390090
Labeler code
69539
Product ID
69539-090_a94a0c14-c037-49e2-80a0-9e273d538c58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA214366
Marketing category
ANDA
Marketing start
2021-05-11
Marketing end
0000-00-00
Substance
ERLOTINIB HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-090ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]1Legacy NDC20210513_a94a0c14-c037-49e2-80a0-9e273d538c58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-090-30695390090301 BOTTLE in 1 CARTON (69539-090-30) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-110000-00-00NoNoCurrent