FDA.reportPublic FDA data

Atomoxetine

Product NDC
35573-420
Requested package NDC
35573-420-30
11-digit product format
355730420
Labeler code
35573
Product ID
35573-420_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
80 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 packagepackage35573-42035573-420-30DDiscontinued by firm2026-07-31

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
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
35573-420-30EA - Each35573-420c8a273bc-7446-4340-8102-9aa85afce42312019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-420-303557304203030 CAPSULE in 1 BOTTLE (35573-420-30) 30 capsule2017-05-300000-00-00NoNoCurrent