FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
50268-059
Requested package NDC
50268-059-13
11-digit product format
502680059
Labeler code
50268
Product ID
50268-059_4587bd5f-1bd2-c809-e063-6294a90adf87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA078983
Marketing category
ANDA
Marketing start
2020-07-07
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
60 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
A078983-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A078983-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A078983-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A078983-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A078983-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A078983-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A078983-007ATOMOXETINE 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
A078983-001AB
A078983-002AB
A078983-003AB
A078983-004AB
A078983-005AB
A078983-006AB
A078983-007AB

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 22:54:322026-06A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-007ATOMOXETINE 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 22:54:322026-06A078983-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-007AB1a50c72e98297…

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
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAK9e787cc2-5d0f-f231-e053-2a95a90ae99a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAKa9df4617-b406-70ba-e053-2995a90a28e82025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
ndc (package): 50268-059-13
ndc (product): 50268-059
ndc11 (package): 50268005913
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEREMEDYREPACK INC.6d7ea8f7-981c-4acc-aeaf-7516325bfc0c2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.6f14ced9-c16c-905a-e053-2a91aa0a031e2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEApotex Corp.132852a6-5bff-15dd-255c-98309dd836302025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEA-S Medication Solutions19b10860-aa08-4480-816c-c207819e5f9e2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE60 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
349595Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9df4617-b406-70ba-e053-2995a90a28e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-059-132025-12-09C16284748780-1d6a99b39-5c9e-a426-e053-dadaa90af4c2ATOMOXETINE capsules, for oral use These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . Initial U.S. Approval: 2002
50268-059-132022-01-28C16284748780-1d6a99b39-5c9e-a426-e053-dadaa90af4c2ATOMOXETINE capsules, for oral use These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-059-11Atomoxetine Hydrochloride1 in 1 BLISTER PACKCAPSULE12
50268-059-13Atomoxetine Hydrochloride30 in 1 BOXCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-059-11EA - Each50268-05970c65c2c-c5d9-4ed1-90f7-11ef00cec29912020-08-06
50268-059-13EA - Each50268-059354c0c74-bb98-4916-a29a-e8a388325f6312020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-059ATOMOXETINE HYDROCHLORIDE CAPSULE [AVPAK]1Current NDC, Legacy NDC, 2 package rows20200708_a9df4617-b406-70ba-e053-2995a90a28e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349595atomoxetine HCl 60 MG Oral CapsulePSNa9df4617-b406-70ba-e053-2995a90a28e82
349595atomoxetine 60 MG Oral CapsuleSCDa9df4617-b406-70ba-e053-2995a90a28e82
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSYa9df4617-b406-70ba-e053-2995a90a28e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-059-135026800591330 BLISTER PACK in 1 BOX (50268-059-13) / 1 CAPSULE in 1 BLISTER PACK (50268-059-11) 30 blister pack2020-07-070000-00-00NoNoCurrent