FDA.reportPublic FDA data

Strattera

Product NDC
0002-3228
11-digit product format
000023228
Labeler code
0002
Product ID
0002-3228_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
25 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021411-001STRATTERAATOMOXETINE HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26
N021411-002STRATTERAATOMOXETINE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-003STRATTERAATOMOXETINE HYDROCHLORIDEEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-004STRATTERAATOMOXETINE HYDROCHLORIDEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-005STRATTERAATOMOXETINE HYDROCHLORIDEEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-006STRATTERAATOMOXETINE HYDROCHLORIDEEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-007STRATTERAATOMOXETINE HYDROCHLORIDEEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14
N021411-008STRATTERAATOMOXETINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021411-001STRATTERAEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-002STRATTERAEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-003STRATTERAEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-004STRATTERAEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-005STRATTERAEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-006STRATTERAEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-007STRATTERAEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14a50c72e98297…
2026-08-01 22:54:322026-06N021411-008STRATTERAEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StratteraATOMOXETINE HYDROCHLORIDEEli Lilly and Company309de576-c318-404a-bc15-660c2b1876fb2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021411
application number: NDA021411
ndc (product): 0002-3228

Additional Listing Data#

Finished product
Yes
Brand name base
Strattera

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57WVB6I2W0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349591Internal RxNorm lookup
349592Internal RxNorm lookup
349593Internal RxNorm lookup
349594Internal RxNorm lookup
349595Internal RxNorm lookup
352317Internal RxNorm lookup
352318Internal RxNorm lookup
352319Internal RxNorm lookup
352320Internal RxNorm lookup
352321Internal RxNorm lookup
608139Internal RxNorm lookup
608143Internal RxNorm lookup
617945Internal RxNorm lookup
617947Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309de576-c318-404a-bc15-660c2b1876fbAvailable on FDA.report

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
0002-3228-30Strattera30 in 1 BOTTLECAPSULE3066

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-3228-30EA - Each0002-3228bf385753-4cc4-45d3-a7cc-4c5a047d581012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOMOXETINE HYDROCHLORIDEACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
ATOMOXETINEACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2037
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 [TYA PHARMACEUTICALS]2
Atomoxetine hydrochlorideACTIVE INGREDIENT57WVB6I2W0STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
AtomoxetineACTIVE MOIETYASW034S0B8STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3228STRATTERA (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
349593atomoxetine HCl 25 MG Oral CapsulePSNfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
349593atomoxetine HCl 25 MG Oral CapsulePSN2da85bec-890d-477a-b347-767eabb27f9c2
352319Strattera 25 MG Oral CapsulePSN2da85bec-890d-477a-b347-767eabb27f9c2
352319Strattera 25 MG Oral CapsulePSNfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319atomoxetine 25 MG Oral Capsule [Strattera]SBDfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319atomoxetine 25 MG Oral Capsule [Strattera]SBD2da85bec-890d-477a-b347-767eabb27f9c2
349593atomoxetine 25 MG Oral CapsuleSCDfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
349593atomoxetine 25 MG Oral CapsuleSCD2da85bec-890d-477a-b347-767eabb27f9c2
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSYfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY2da85bec-890d-477a-b347-767eabb27f9c2
352319Strattera 25 MG Oral CapsuleSYfd1c71bc-1445-4ac6-8a8d-79050e61b03a2
352319Strattera 25 MG Oral CapsuleSY2da85bec-890d-477a-b347-767eabb27f9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-3228-300000232283030 CAPSULE in 1 BOTTLE (0002-3228-30) 30 capsule2003-01-102027-07-31NoNoCurrent