FDA.reportPublic FDA data

Erlotinib

Product NDC
63304-135
11-digit product format
633040135
Labeler code
63304
Product ID
63304-135_c160713b-c06f-49b4-80ea-fc1afb030b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA210300
Marketing category
ANDA
Marketing start
2019-11-05
Substance
ERLOTINIB
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
ERLOTINIB150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ4T82NDH7E
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
63304-135-11Erlotinib3 in 1 CARTONTABLET, FILM COATED33
63304-135-30Erlotinib30 in 1 BOTTLETABLET, FILM COATED303
63304-135-31Erlotinib10 in 1 BLISTER PACKTABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-135-30EA - Each63304-135d2a71666-bf7e-4cb7-bd59-563a16cdeecf12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-135ERLOTINIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 3 package rows20191106_e36fa076-e23b-437f-bbd2-0433ce333175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSNe36fa076-e23b-437f-bbd2-0433ce3331753
603206erlotinib 150 MG Oral TabletPSNe36fa076-e23b-437f-bbd2-0433ce3331753
603208erlotinib 25 MG Oral TabletPSNe36fa076-e23b-437f-bbd2-0433ce3331753
603203erlotinib 100 MG Oral TabletSCDe36fa076-e23b-437f-bbd2-0433ce3331753
603206erlotinib 150 MG Oral TabletSCDe36fa076-e23b-437f-bbd2-0433ce3331753
603208erlotinib 25 MG Oral TabletSCDe36fa076-e23b-437f-bbd2-0433ce3331753
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSYe36fa076-e23b-437f-bbd2-0433ce3331753
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSYe36fa076-e23b-437f-bbd2-0433ce3331753
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSYe36fa076-e23b-437f-bbd2-0433ce3331753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-135-11633040135113 BLISTER PACK in 1 CARTON (63304-135-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-135-31) 3 blister pack2019-11-050000-00-00NoNoCurrent
63304-135-306330401353030 TABLET, FILM COATED in 1 BOTTLE (63304-135-30) 2019-11-050000-00-00NoNoCurrent
63304-135-316330401353110 in 1 BLISTER PACKHistorical