Atomoxetine

Product NDC
63629-9427
11-digit product format
636299427
Labeler code
63629
Product ID
63629-9427_42ef39aa-5c53-44e0-b9c9-4426104749f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090609
Marketing category
ANDA
Marketing start
2018-02-23
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
40 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
63629-9427-16362994270130 CAPSULE in 1 BOTTLE (63629-9427-1) 30 capsule2022-08-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AtomoxetineBryant Ranch Prepack2023-10-20HUMAN PRESCRIPTION DRUG LABEL101