Atomoxetine

Product NDC
35573-420
11-digit product format
355730420
Labeler code
35573
Product ID
35573-420_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
80 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
35573-420-30EA - Each35573-420c8a273bc-7446-4340-8102-9aa85afce42312019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-420-303557304203030 CAPSULE in 1 BOTTLE (35573-420-30) 30 capsule2017-05-300000-00-00NoNoCurrent