FDA.reportPublic FDA data

Erlotinib

Product NDC
72485-219
11-digit product format
724850219
Labeler code
72485
Product ID
72485-219_e7a350dc-b9b0-4650-9cb6-2948162a8e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA211960
Marketing category
ANDA
Marketing start
2019-11-06
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
Rxcui603206

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
72485-219-30Erlotinib30 in 1 BOTTLETABLET, FILM COATED301
72485-219-30Erlotinib1 in 1 BOXTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-219-30EA - Each72485-219c4a14e43-f92c-484b-80ca-9766ac20d89212019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-219ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20191110_766baa46-1916-44e8-b599-33017a4194f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603206erlotinib 150 MG Oral TabletPSN766baa46-1916-44e8-b599-33017a4194f11
603206erlotinib 150 MG Oral TabletSCD766baa46-1916-44e8-b599-33017a4194f11
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSY766baa46-1916-44e8-b599-33017a4194f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-219-30724850219301 BOTTLE in 1 BOX (72485-219-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-060000-00-00NoNoCurrent