FDA.reportPublic FDA data

Strattera

Product NDC
0002-3238
11-digit product format
000023238
Labeler code
0002
Product ID
0002-3238_8360d9e6-0df4-4969-9efa-7c01e69d6947
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA021411
Marketing category
NDA
Marketing start
2002-11-26
Marketing end
2027-07-31
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
18 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Strattera

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE18 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, 608139, 608143, 617945, 617947

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
0002-3238-30Strattera30 in 1 BOTTLECAPSULE3066

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-3238-30EA - Each0002-32385d459d13-9dd7-4305-b619-76cbbfb23f6712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atomoxetine hydrochlorideACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
GelatinINACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
STARCH, CornINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]54
Atomoxetine hydrochlorideACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
ATOMOXETINE HYDROCHLORIDEACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
ATOMOXETINEACTIVE MOIETYASW034S0B8STRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMXETINE HYROCHLORIDE ) CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3238STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY ]65Current NDC, Legacy NDC, 1 package rows20241115_309de576-c318-404a-bc15-660c2b1876fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
608139atomoxetine HCl 100 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
349592atomoxetine HCl 18 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
349593atomoxetine HCl 25 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
349594atomoxetine HCl 40 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
349595atomoxetine HCl 60 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
608143atomoxetine HCl 80 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352317Strattera 10 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
617945Strattera 100 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352318Strattera 18 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352319Strattera 25 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352320Strattera 40 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352321Strattera 60 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
617947Strattera 80 MG Oral CapsulePSN309de576-c318-404a-bc15-660c2b1876fb66
352317atomoxetine 10 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
617945atomoxetine 100 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
352318atomoxetine 18 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
352319atomoxetine 25 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
352320atomoxetine 40 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
352321atomoxetine 60 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
617947atomoxetine 80 MG Oral Capsule [Strattera]SBD309de576-c318-404a-bc15-660c2b1876fb66
349591atomoxetine 10 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
608139atomoxetine 100 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
349592atomoxetine 18 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
349593atomoxetine 25 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
349594atomoxetine 40 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
349595atomoxetine 60 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
608143atomoxetine 80 MG Oral CapsuleSCD309de576-c318-404a-bc15-660c2b1876fb66
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
352317Strattera 10 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
617945Strattera 100 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
352318Strattera 18 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
352319Strattera 25 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
352320Strattera 40 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
352321Strattera 60 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
617947Strattera 80 MG Oral CapsuleSY309de576-c318-404a-bc15-660c2b1876fb66
349592atomoxetine HCl 18 MG Oral CapsulePSNb080e703-3fab-4914-8529-ffaa59da693d2
352318Strattera 18 MG Oral CapsulePSNb080e703-3fab-4914-8529-ffaa59da693d2
352318atomoxetine 18 MG Oral Capsule [Strattera]SBDb080e703-3fab-4914-8529-ffaa59da693d2
349592atomoxetine 18 MG Oral CapsuleSCDb080e703-3fab-4914-8529-ffaa59da693d2
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSYb080e703-3fab-4914-8529-ffaa59da693d2
352318Strattera 18 MG Oral CapsuleSYb080e703-3fab-4914-8529-ffaa59da693d2
349591atomoxetine HCl 10 MG Oral CapsulePSNf8f80fca-32b7-4fba-b0ab-e87530bc36b61
352317Strattera 10 MG Oral CapsulePSNf8f80fca-32b7-4fba-b0ab-e87530bc36b61
352317atomoxetine 10 MG Oral Capsule [Strattera]SBDf8f80fca-32b7-4fba-b0ab-e87530bc36b61
349591atomoxetine 10 MG Oral CapsuleSCDf8f80fca-32b7-4fba-b0ab-e87530bc36b61
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSYf8f80fca-32b7-4fba-b0ab-e87530bc36b61
352317Strattera 10 MG Oral CapsuleSYf8f80fca-32b7-4fba-b0ab-e87530bc36b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-3238-300000232383030 CAPSULE in 1 BOTTLE (0002-3238-30) 30 capsule2003-01-102027-07-31NoNoCurrent