FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
50090-4236
11-digit product format
500904236
Labeler code
50090
Product ID
50090-4236_d1a130e7-3cee-40cf-a4c6-cb3893304987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078983
Marketing category
ANDA
Marketing start
2018-05-21
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
40 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
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
ndc (product): 50090-4236

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE40 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
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
19b10860-aa08-4480-816c-c207819e5f9eAvailable 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
50090-4236-02023-02-07C16284748780-1f386c649-b91b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002
50090-4236-02023-01-30C16284748780-1f386c649-b91b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4236-0Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4236-0EA - Each50090-4236b7b5525e-3cd7-47db-ab89-d151d8f6904b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4236ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20230208_19b10860-aa08-4480-816c-c207819e5f9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSN19b10860-aa08-4480-816c-c207819e5f9e7
349594atomoxetine 40 MG Oral CapsuleSCD19b10860-aa08-4480-816c-c207819e5f9e7
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY19b10860-aa08-4480-816c-c207819e5f9e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4236-05009042360030 CAPSULE in 1 BOTTLE (50090-4236-0) 30 capsule2019-03-290000-00-00NoNoCurrent