FDA.reportPublic FDA data

Atomoxetine

Product NDC
42291-068
11-digit product format
422910068
Labeler code
42291
Product ID
42291-068_485b5018-57ec-90d7-e063-6294a90ae5e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA079022
Marketing category
ANDA
Marketing start
2022-04-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE60 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
42291-068-30Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-068-30EA - Each42291-068cd452239-aea6-4eb6-acaa-8916b0cd3c7312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-068ATOMOXETINE CAPSULE [AVKARE]2Current NDC, Legacy NDC, 1 package rows20240110_dc7ba02c-bdbb-5136-e053-2995a90ac545.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
608139atomoxetine HCl 100 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
349592atomoxetine HCl 18 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
349593atomoxetine HCl 25 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
349594atomoxetine HCl 40 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
349595atomoxetine HCl 60 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
608143atomoxetine HCl 80 MG Oral CapsulePSNdc7ba02c-bdbb-5136-e053-2995a90ac5453
349591atomoxetine 10 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
608139atomoxetine 100 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
349592atomoxetine 18 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
349593atomoxetine 25 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
349594atomoxetine 40 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
349595atomoxetine 60 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
608143atomoxetine 80 MG Oral CapsuleSCDdc7ba02c-bdbb-5136-e053-2995a90ac5453
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSYdc7ba02c-bdbb-5136-e053-2995a90ac5453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-068-304229100683030 CAPSULE in 1 BOTTLE (42291-068-30) 30 capsule2022-04-120000-00-00NoNoCurrent