FDA.reportPublic FDA data

ERLOTINIB HYDROCHLORIDE

Product NDC
46708-566
11-digit product format
467080566
Labeler code
46708
Product ID
46708-566_966e67f7-6259-4b1c-8c6a-b2589d57e1ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERLOTINIB HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA214719
Marketing category
ANDA
Marketing start
2021-07-09
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 HYDROCHLORIDE
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-566-302023-02-01C16284748780-1f386c649-f1ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS. ERLOTINIB tablets, for oral use Initial U.S. Approval: 2004
46708-566-902023-02-01C16284748780-1f386c649-f1ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS. ERLOTINIB tablets, for oral use Initial U.S. Approval: 2004
46708-566-302023-01-30C16284748780-1f386c649-f1ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS. ERLOTINIB tablets, for oral use Initial U.S. Approval: 2004
46708-566-902023-01-30C16284748780-1f386c649-f1ef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS. ERLOTINIB tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-566-30ERLOTINIB HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
46708-566-90ERLOTINIB HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-566ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20240612_ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSNab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603206erlotinib 150 MG Oral TabletPSNab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603208erlotinib 25 MG Oral TabletPSNab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603203erlotinib 100 MG Oral TabletSCDab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603206erlotinib 150 MG Oral TabletSCDab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603208erlotinib 25 MG Oral TabletSCDab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSYab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSYab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSYab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-566-304670805663030 TABLET, FILM COATED in 1 BOTTLE (46708-566-30) 2021-07-090000-00-00NoNoCurrent
46708-566-904670805669090 TABLET, FILM COATED in 1 BOTTLE (46708-566-90) 2021-07-090000-00-00NoNoCurrent