Atomoxetine

Product NDC
72162-2546
11-digit product format
721622546
Labeler code
72162
Product ID
72162-2546_8e3ce9fe-7411-4e52-95c1-52d96096066a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079021
Marketing category
ANDA
Marketing start
2025-07-01
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
57WVB6I2W0ATOMOXETINE HYDROCHLORIDE82248-59-7ATOMOXETINE HYDROCHLORIDE
ASW034S0B8ATOMOXETINE83015-26-3Atomoxetine

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2546-37216225460330 CAPSULE in 1 BOTTLE (72162-2546-3) 30 capsule2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AtomoxetineBryant Ranch Prepack2025-10-16HUMAN PRESCRIPTION DRUG LABEL100