Atomoxetine

Product NDC
65862-244
11-digit product format
658620244
Labeler code
65862
Product ID
65862-244_48d5f73a-bdcc-466a-aa17-53c0a38c3b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
100 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
65862-244-0565862024405500 CAPSULE in 1 BOTTLE (65862-244-05) 500 capsule2017-05-30NoNoHistorical
65862-244-306586202443030 CAPSULE in 1 BOTTLE (65862-244-30) 30 capsule2017-05-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AtomoxetineAurobindo Pharma Limited2025-12-12Human Prescription Drug Label16