FDA.reportPublic FDA data

Atomoxetine

Product NDC
65862-238
11-digit product format
658620238
Labeler code
65862
Product ID
65862-238_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
10 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

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349591, 349592, 349593, 349594, 349595, 608139, 608143

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-238-22Atomoxetine2000 in 1 BOTTLECAPSULE200016
65862-238-30Atomoxetine30 in 1 BOTTLECAPSULE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-238ATOMOXETINE CAPSULE [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20240215_6f6bea0c-297b-43ff-8960-ecc11243e06e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine HCl 100 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine HCl 18 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine HCl 25 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine HCl 40 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine HCl 60 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine HCl 80 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349591atomoxetine 10 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine 100 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine 18 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine 25 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine 40 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine 60 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine 80 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-238-22658620238222000 CAPSULE in 1 BOTTLE (65862-238-22) 2000 capsule2017-05-300000-00-00NoNoCurrent
65862-238-306586202383030 CAPSULE in 1 BOTTLE (65862-238-30) 30 capsule2017-05-300000-00-00NoNoCurrent