Atomoxetine Hydrochloride

Product NDC
50090-4243
Requested package NDC
50090-4243-0
11-digit product format
500904243
Labeler code
50090
Product ID
50090-4243_3f82534e-1d3b-4707-a042-5832b649d7a8
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
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-424350090-4243-0IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078983-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078983-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078983-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078983-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078983-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078983-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078983-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078983-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078983-005AB1b8a1b40f171c…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4243-0Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4243ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210617_8b7637ba-0541-41ef-bb54-1940fbbb8c64.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEApotex Corp.132852a6-5bff-15dd-255c-98309dd836302026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
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 HYDROCHLORIDEA-S Medication Solutions19b10860-aa08-4480-816c-c207819e5f9e2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608143atomoxetine HCl 80 MG Oral CapsulePSN8b7637ba-0541-41ef-bb54-1940fbbb8c647
608143atomoxetine 80 MG Oral CapsuleSCD8b7637ba-0541-41ef-bb54-1940fbbb8c647
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY8b7637ba-0541-41ef-bb54-1940fbbb8c647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4243-05009042430030 CAPSULE in 1 BOTTLE (50090-4243-0) 30 capsule2019-03-290000-00-00NoNoCurrent