FDA.reportPublic FDA data

Erlotinib Hydrochloride

Product NDC
72205-082
11-digit product format
722050082
Labeler code
72205
Product ID
72205-082_4cff04f5-3693-4d87-a9f8-a2b195e3d26e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erlotinib Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214366
Marketing category
ANDA
Marketing start
2021-05-11
Substance
ERLOTINIB HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERLOTINIB HYDROCHLORIDE150 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
72205-082-30Erlotinib Hydrochloride1 in 1 CARTONTABLET, FILM COATED11
72205-082-30Erlotinib Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-082-30EA - Each72205-0825fbf5a1b-104d-42fe-88e2-2be7560a9e4512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-082ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20210513_4cff04f5-3693-4d87-a9f8-a2b195e3d26e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603203erlotinib 100 MG Oral TabletPSN4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603206erlotinib 150 MG Oral TabletPSN4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603208erlotinib 25 MG Oral TabletPSN4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603203erlotinib 100 MG Oral TabletSCD4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603206erlotinib 150 MG Oral TabletSCD4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603208erlotinib 25 MG Oral TabletSCD4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603208erlotinib (as erlotinib hydrochloride) 25 MG Oral TabletSY4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603203erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral TabletSY4cff04f5-3693-4d87-a9f8-a2b195e3d26e1
603206erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral TabletSY4cff04f5-3693-4d87-a9f8-a2b195e3d26e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-082-30722050082301 BOTTLE in 1 CARTON (72205-082-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-110000-00-00NoNoCurrent