FDA.reportPublic FDA data

TARCEVA

Product NDC
50242-064
11-digit product format
502420064
Labeler code
50242
Product ID
50242-064_5c1bf1f1-3ef7-4411-9305-b4f4080b769a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erlotinib hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA021743
Marketing category
NDA
Marketing start
2005-04-30
Marketing end
0000-00-00
Substance
ERLOTINIB HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-064-01EA - Each50242-064dfb29a40-f6e1-4463-ac8f-f8e60d7d7b5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
erlotinib hydrochlorideACTIVE INGREDIENTDA87705X9KTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]12
ERLOTINIBACTIVE MOIETYJ4T82NDH7ETARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]12
ERLOTINIB HYDROCHLORIDEACTIVE INGREDIENTDA87705X9KTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
ERLOTINIBACTIVE MOIETYJ4T82NDH7ETARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-064TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]16Legacy NDC20181220_57bccb29-1c47-4c64-ab6a-77960a91cc20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
603206erlotinib 150 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
603208erlotinib 25 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
1088251Tarceva 100 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
1088253Tarceva 150 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
1088255Tarceva 25 MG Oral TabletPSN5783976b-0862-44e5-9b19-0f41d236d5c31
1088251erlotinib 100 MG Oral Tablet [Tarceva]SBD5783976b-0862-44e5-9b19-0f41d236d5c31
1088253erlotinib 150 MG Oral Tablet [Tarceva]SBD5783976b-0862-44e5-9b19-0f41d236d5c31
1088255erlotinib 25 MG Oral Tablet [Tarceva]SBD5783976b-0862-44e5-9b19-0f41d236d5c31
603203erlotinib 100 MG Oral TabletSCD5783976b-0862-44e5-9b19-0f41d236d5c31
603206erlotinib 150 MG Oral TabletSCD5783976b-0862-44e5-9b19-0f41d236d5c31
603208erlotinib 25 MG Oral TabletSCD5783976b-0862-44e5-9b19-0f41d236d5c31
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31
1088251Tarceva 100 MG Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31
1088253Tarceva 150 MG Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31
1088255Tarceva 25 MG Oral TabletSY5783976b-0862-44e5-9b19-0f41d236d5c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-064-015024200640130 TABLET in 1 BOTTLE (50242-064-01) 30 tablet2005-04-300000-00-00NoNoCurrent