FDA.reportPublic FDA data

Erlotinib

Product NDC
70771-1522
11-digit product format
707711522
Labeler code
70771
Product ID
70771-1522_9d253beb-cd1f-45df-9b23-c521269d419f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA213065
Marketing category
ANDA
Marketing start
2020-04-30
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
70771-1522-2Erlotinib10 in 1 BLISTER PACKTABLET, FILM COATED103
70771-1522-3Erlotinib30 in 1 BOTTLETABLET, FILM COATED303
70771-1522-7Erlotinib3 in 1 CARTONTABLET, FILM COATED33
70771-1522-9Erlotinib90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1522ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 4 package rows20241201_daaa1329-3a3f-439c-b13d-b301daa234d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSNdaaa1329-3a3f-439c-b13d-b301daa234d43
603206erlotinib 150 MG Oral TabletPSNdaaa1329-3a3f-439c-b13d-b301daa234d43
603208erlotinib 25 MG Oral TabletPSNdaaa1329-3a3f-439c-b13d-b301daa234d43
603203erlotinib 100 MG Oral TabletSCDdaaa1329-3a3f-439c-b13d-b301daa234d43
603206erlotinib 150 MG Oral TabletSCDdaaa1329-3a3f-439c-b13d-b301daa234d43
603208erlotinib 25 MG Oral TabletSCDdaaa1329-3a3f-439c-b13d-b301daa234d43
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSYdaaa1329-3a3f-439c-b13d-b301daa234d43
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSYdaaa1329-3a3f-439c-b13d-b301daa234d43
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSYdaaa1329-3a3f-439c-b13d-b301daa234d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1522-27077115220210 in 1 BLISTER PACKHistorical
70771-1522-37077115220330 TABLET, FILM COATED in 1 BOTTLE (70771-1522-3) 2020-04-300000-00-00NoNoCurrent
70771-1522-7707711522073 BLISTER PACK in 1 CARTON (70771-1522-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1522-2) 3 blister pack2020-04-300000-00-00NoNoCurrent
70771-1522-97077115220990 TABLET, FILM COATED in 1 BOTTLE (70771-1522-9) 2020-04-300000-00-00NoNoCurrent