FDA.reportPublic FDA data

Erlotinib

Product NDC
72485-218
11-digit product format
724850218
Labeler code
72485
Product ID
72485-218_bc4532f4-6a0a-4fd1-a630-8b524c02c7aa
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
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

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
72485-218-30Erlotinib1 in 1 BOXTABLET, FILM COATED11
72485-218-30Erlotinib30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-218-30EA - Each72485-2181b55b054-3862-42c7-a51c-d1f1f0a0930b12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-218ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20191110_2c4c7353-b81c-4651-8aac-6d15e88145af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSN2c4c7353-b81c-4651-8aac-6d15e88145af1
603203erlotinib 100 MG Oral TabletSCD2c4c7353-b81c-4651-8aac-6d15e88145af1
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSY2c4c7353-b81c-4651-8aac-6d15e88145af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-218-30724850218301 BOTTLE in 1 BOX (72485-218-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-060000-00-00NoNoCurrent