FDA.reportPublic FDA data

Erlotinib

Product NDC
59651-531
11-digit product format
596510531
Labeler code
59651
Product ID
59651-531_3ecafc1e-979a-4aff-a276-18fc0b110491
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216342
Marketing category
ANDA
Marketing start
2022-06-22
Substance
ERLOTINIB HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 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
59651-531-03Erlotinib30 in 1 BOTTLETABLET, FILM COATED301
59651-531-10Erlotinib1 in 1 CARTONTABLET, FILM COATED11
59651-531-10Erlotinib10 in 1 BLISTER PACKTABLET, FILM COATED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-531ERLOTINIB TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 3 package rows20220630_3ecafc1e-979a-4aff-a276-18fc0b110491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSN3ecafc1e-979a-4aff-a276-18fc0b1104911
603206erlotinib 150 MG Oral TabletPSN3ecafc1e-979a-4aff-a276-18fc0b1104911
603208erlotinib 25 MG Oral TabletPSN3ecafc1e-979a-4aff-a276-18fc0b1104911
603203erlotinib 100 MG Oral TabletSCD3ecafc1e-979a-4aff-a276-18fc0b1104911
603206erlotinib 150 MG Oral TabletSCD3ecafc1e-979a-4aff-a276-18fc0b1104911
603208erlotinib 25 MG Oral TabletSCD3ecafc1e-979a-4aff-a276-18fc0b1104911
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSY3ecafc1e-979a-4aff-a276-18fc0b1104911
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSY3ecafc1e-979a-4aff-a276-18fc0b1104911
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSY3ecafc1e-979a-4aff-a276-18fc0b1104911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-531-035965105310330 TABLET, FILM COATED in 1 BOTTLE (59651-531-03) 2022-06-220000-00-00NoNoCurrent
59651-531-10596510531101 BLISTER PACK in 1 CARTON (59651-531-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-06-220000-00-00NoNoCurrent