FDA.reportPublic FDA data

ERLOTINIB HYDROCHLORIDE

Product NDC
62332-565
11-digit product format
623320565
Labeler code
62332
Product ID
62332-565_78cde6f1-5cd7-428e-8ae8-e707d4d5f484
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERLOTINIB HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214719
Marketing category
ANDA
Marketing start
2021-07-09
Substance
ERLOTINIB HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERLOTINIB HYDROCHLORIDE25 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
62332-565-30ERLOTINIB HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
62332-565-90ERLOTINIB HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-565-30EA - Each62332-565ab5e4d47-8211-48be-ad91-3e6fd8abdf4c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-565ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20230219_ccf1e415-4980-462f-8ac2-87979bda149e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSNccf1e415-4980-462f-8ac2-87979bda149e4
603206erlotinib 150 MG Oral TabletPSNccf1e415-4980-462f-8ac2-87979bda149e4
603208erlotinib 25 MG Oral TabletPSNccf1e415-4980-462f-8ac2-87979bda149e4
603203erlotinib 100 MG Oral TabletSCDccf1e415-4980-462f-8ac2-87979bda149e4
603206erlotinib 150 MG Oral TabletSCDccf1e415-4980-462f-8ac2-87979bda149e4
603208erlotinib 25 MG Oral TabletSCDccf1e415-4980-462f-8ac2-87979bda149e4
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSYccf1e415-4980-462f-8ac2-87979bda149e4
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSYccf1e415-4980-462f-8ac2-87979bda149e4
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSYccf1e415-4980-462f-8ac2-87979bda149e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-565-306233205653030 TABLET, FILM COATED in 1 BOTTLE (62332-565-30) 2021-07-090000-00-00NoNoCurrent
62332-565-906233205659090 TABLET, FILM COATED in 1 BOTTLE (62332-565-90) 2021-07-090000-00-00NoNoCurrent