Atomoxetine

Product NDC
63629-9428
11-digit product format
636299428
Labeler code
63629
Product ID
63629-9428_b91d2f70-9d03-4d24-9efc-cd921643075f
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
60 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
63629-9428-16362994280130 CAPSULE in 1 BOTTLE (63629-9428-1) 30 capsule2022-08-23NoNoHistorical

Related DailyMed Labels

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