FDA.reportPublic FDA data

Atomoxetine

Product NDC
42291-066
11-digit product format
422910066
Labeler code
42291
Product ID
42291-066_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
25 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

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079022-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A079022-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A079022-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A079022-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A079022-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A079022-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A079022-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A079022-001AB
A079022-002AB
A079022-003AB
A079022-004AB
A079022-005AB
A079022-006AB
A079022-007AB

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 22:54:322026-06A079022-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079022-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079022-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079022-007AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINEAvKAREdc7ba02c-bdbb-5136-e053-2995a90ac5452026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
ndc (product): 42291-066
AtomoxetineATOMOXETINEA-S Medication Solutionsddec2943-483d-403a-838c-cbdb6eefe0a12025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
AtomoxetineATOMOXETINEA-S Medication Solutions96855061-440f-4c99-a152-cf8da8e2b1b32023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
AtomoxetineATOMOXETINEA-S Medication Solutionsaa109260-6d4c-429c-9957-19cbe0e344852023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
AtomoxetineATOMOXETINEA-S Medication Solutions402711d7-bd44-4f2a-ad2b-4756cdc686452023-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
AtomoxetineATOMOXETINETeva Pharmaceuticals USA, Inc.4953df7b-ccdb-452c-8699-5fd7259609b42023-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022

Additional Listing Data#

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

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 · 7 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
608139Internal RxNorm lookup
608143Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc7ba02c-bdbb-5136-e053-2995a90ac545Available 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
42291-066-30Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-066-30EA - Each42291-06684af4692-a917-4c86-bccd-ad1a3cee3f9f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-066ATOMOXETINE 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
42291-066-304229100663030 CAPSULE in 1 BOTTLE (42291-066-30) 30 capsule2022-04-120000-00-00NoNoCurrent