FDA.reportPublic FDA data

Erlotinib

Product NDC
68382-913
11-digit product format
683820913
Labeler code
68382
Product ID
68382-913_e34fafdf-2fda-4031-9202-6d7e85925dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA213065
Marketing category
ANDA
Marketing start
2020-04-30
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
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
68382-913-06Erlotinib30 in 1 BOTTLETABLET303
68382-913-16Erlotinib90 in 1 BOTTLETABLET903
68382-913-30Erlotinib10 in 1 BLISTER PACKTABLET103
68382-913-84Erlotinib3 in 1 CARTONTABLET33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-913-06EA - Each68382-9133928ab1c-cdef-4309-86e4-2234067ceea012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-913ERLOTINIB TABLET [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 4 package rows20231011_c35e019d-ec34-4e61-9400-a7ae7913e025.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSNc35e019d-ec34-4e61-9400-a7ae7913e0253
603206erlotinib 150 MG Oral TabletPSNc35e019d-ec34-4e61-9400-a7ae7913e0253
603208erlotinib 25 MG Oral TabletPSNc35e019d-ec34-4e61-9400-a7ae7913e0253
603203erlotinib 100 MG Oral TabletSCDc35e019d-ec34-4e61-9400-a7ae7913e0253
603206erlotinib 150 MG Oral TabletSCDc35e019d-ec34-4e61-9400-a7ae7913e0253
603208erlotinib 25 MG Oral TabletSCDc35e019d-ec34-4e61-9400-a7ae7913e0253
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSYc35e019d-ec34-4e61-9400-a7ae7913e0253
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSYc35e019d-ec34-4e61-9400-a7ae7913e0253
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSYc35e019d-ec34-4e61-9400-a7ae7913e0253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-913-066838209130630 TABLET in 1 BOTTLE (68382-913-06) 30 tablet2020-04-300000-00-00NoNoCurrent
68382-913-166838209131690 TABLET in 1 BOTTLE (68382-913-16) 90 tablet2020-04-300000-00-00NoNoCurrent
68382-913-306838209133010 in 1 BLISTER PACKHistorical
68382-913-84683820913843 BLISTER PACK in 1 CARTON (68382-913-84) / 10 TABLET in 1 BLISTER PACK (68382-913-30) 3 blister pack2020-04-300000-00-00NoNoCurrent