FDA.reportPublic FDA data

Atomoxetine

Product NDC
0093-3542
11-digit product format
000933542
Labeler code
0093
Product ID
0093-3542_6b86d06c-1e99-484b-9643-5ed88511f045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079022
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
0093-3542-56Atomoxetine30 in 1 BOTTLECAPSULE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3542-56EA - Each0093-3542b84478dd-726a-40b2-98bb-d31681cf0ce412017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3542ATOMOXETINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 1 package rows20240214_4953df7b-ccdb-452c-8699-5fd7259609b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
608139atomoxetine HCl 100 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
349592atomoxetine HCl 18 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
349593atomoxetine HCl 25 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
349594atomoxetine HCl 40 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
349595atomoxetine HCl 60 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
608143atomoxetine HCl 80 MG Oral CapsulePSN4953df7b-ccdb-452c-8699-5fd7259609b418
349591atomoxetine 10 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
608139atomoxetine 100 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
349592atomoxetine 18 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
349593atomoxetine 25 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
349594atomoxetine 40 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
349595atomoxetine 60 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
608143atomoxetine 80 MG Oral CapsuleSCD4953df7b-ccdb-452c-8699-5fd7259609b418
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY4953df7b-ccdb-452c-8699-5fd7259609b418
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
0093-3542-560009335425630 CAPSULE in 1 BOTTLE (0093-3542-56) 30 capsule2017-05-300000-00-00NoNoCurrent