FDA.reportPublic FDA data

Atomoxetine

Product NDC
50090-6511
11-digit product format
500906511
Labeler code
50090
Product ID
50090-6511_c69ae8cb-d0e7-444f-a102-ebc42e6609a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079022
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
80 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

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
AtomoxetineATOMOXETINEA-S Medication Solutionsddec2943-483d-403a-838c-cbdb6eefe0a12025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079022
application number: ANDA079022
ndc (product): 50090-6511
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE80 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ddec2943-483d-403a-838c-cbdb6eefe0a1Available 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
50090-6511-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6511-0EA - Each50090-65118d478899-a769-4cb3-8f84-407c8813059f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6511ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230608_ddec2943-483d-403a-838c-cbdb6eefe0a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608143atomoxetine HCl 80 MG Oral CapsulePSNddec2943-483d-403a-838c-cbdb6eefe0a13
608143atomoxetine 80 MG Oral CapsuleSCDddec2943-483d-403a-838c-cbdb6eefe0a13
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSYddec2943-483d-403a-838c-cbdb6eefe0a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6511-05009065110030 CAPSULE in 1 BOTTLE (50090-6511-0) 30 capsule2023-05-31NoNoCurrent