Erlotinib

Product NDC
0093-7664
11-digit product format
000937664
Labeler code
0093
Product ID
0093-7664_4368f7b2-5bdb-4232-90b0-f6a769d71e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091059
Marketing category
ANDA
Marketing start
2019-05-09
Substance
ERLOTINIB HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Erlotinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERLOTINIB HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDA87705X9K
Rxcui603203, 603206, 603208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bd23d1a5-e4ff-4f92-da3b-5034c014ad1aProduct name820250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7664-56Erlotinib30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7664-56EA - Each0093-76645eaabef5-166a-4139-a0c2-72ceeb2163a712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7664ERLOTINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]7Current NDC, Legacy NDC, 1 package rows20211209_5d97f401-4853-4a9a-907d-21e8a4d16088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSN5d97f401-4853-4a9a-907d-21e8a4d160887
603206erlotinib 150 MG Oral TabletPSN5d97f401-4853-4a9a-907d-21e8a4d160887
603208erlotinib 25 MG Oral TabletPSN5d97f401-4853-4a9a-907d-21e8a4d160887
603203erlotinib 100 MG Oral TabletSCD5d97f401-4853-4a9a-907d-21e8a4d160887
603206erlotinib 150 MG Oral TabletSCD5d97f401-4853-4a9a-907d-21e8a4d160887
603208erlotinib 25 MG Oral TabletSCD5d97f401-4853-4a9a-907d-21e8a4d160887
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSY5d97f401-4853-4a9a-907d-21e8a4d160887
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSY5d97f401-4853-4a9a-907d-21e8a4d160887
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSY5d97f401-4853-4a9a-907d-21e8a4d160887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7664-560009376645630 TABLET, FILM COATED in 1 BOTTLE (0093-7664-56) 2019-05-090000-00-00NoNoCurrent