Atomoxetine

Product NDC
35573-417
11-digit product format
355730417
Labeler code
35573
Product ID
35573-417_afa582f8-8dc3-4020-81c6-f26a26907eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
Marketing end
0000-00-00
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-417-30EA - Each35573-41772188fcd-2fe5-4791-b110-f698c69adf6812019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-417-303557304173030 CAPSULE in 1 BOTTLE (35573-417-30) 30 capsule2017-05-300000-00-00NoNoCurrent