FDA.reportPublic FDA data

Atomoxetine

Product NDC
60687-567
11-digit product format
606870567
Labeler code
60687
Product ID
60687-567_2759be5a-a8a1-2119-e063-6394a90a38ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079016
Marketing category
ANDA
Marketing start
2020-12-07
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
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
A079016-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A079016-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A079016-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A079016-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A079016-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A079016-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A079016-007ATOMOXETINE 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
A079016-001AB
A079016-002AB
A079016-003AB
A079016-004AB
A079016-005AB
A079016-006AB
A079016-007AB

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 22:54:322026-06A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-007ATOMOXETINE 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 22:54:322026-06A079016-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-007AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINEAmerican Health Packaging10d36b32-0202-4c03-8a1a-cd5d53f231e72026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
ndc (product): 60687-567
AtomoxetineATOMOXETINEBryant Ranch Prepack35b42f0c-a183-478b-bced-652dc12b33ec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEAurobindo Pharma Limited6f6bea0c-297b-43ff-8960-ecc11243e06e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINERising Pharma Holdings, Inc.1cceab35-dc4a-40bc-a245-10b64820e2172025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutions50a20478-5f33-4ecd-b5d3-dbba855e5f6b2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEBryant Ranch Prepackd4fe9217-1853-4f8b-9a93-77e511554ca12025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutions24bb7238-7e12-48d1-a572-2c753e69f6042023-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutionsffdcc267-d6ae-41ee-97d9-2c7596545ce82023-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349593Internal RxNorm lookup
349594Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10d36b32-0202-4c03-8a1a-cd5d53f231e7Available 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
60687-567-11Atomoxetine1 in 1 BLISTER PACKCAPSULE17
60687-567-21Atomoxetine30 in 1 BOX, UNIT-DOSECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-567ATOMOXETINE CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241122_10d36b32-0202-4c03-8a1a-cd5d53f231e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine HCl 40 MG Oral CapsulePSN10d36b32-0202-4c03-8a1a-cd5d53f231e77
349593atomoxetine 25 MG Oral CapsuleSCD10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine 40 MG Oral CapsuleSCD10d36b32-0202-4c03-8a1a-cd5d53f231e77
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY10d36b32-0202-4c03-8a1a-cd5d53f231e77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-567-11606870567111 in 1 BLISTER PACKHistorical
60687-567-216068705672130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-567-21) / 1 CAPSULE in 1 BLISTER PACK (60687-567-11) 30 blister pack2020-12-070000-00-00NoNoCurrent