Atomoxetine

Product NDC
35573-417
Requested package NDC
35573-417-30
11-digit product format
355730417
Labeler code
35573
Product ID
35573-417_afa582f8-8dc3-4020-81c6-f26a26907eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35573-41735573-417-30DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35573-41735573-417-30DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…

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.

Product history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-3003ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079016-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079016-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079016-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079016-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079016-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079016-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079016-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079016-005AB103ed91905a0d…

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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-417-30EA - Each35573-41772188fcd-2fe5-4791-b110-f698c69adf6812019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-417-303557304173030 CAPSULE in 1 BOTTLE (35573-417-30) 30 capsule2017-05-300000-00-00NoNoCurrent