FDA.reportPublic FDA data

atomoxetine

Product NDC
65841-609
Requested package NDC
65841-609-10
11-digit product format
658410609
Labeler code
65841
Product ID
65841-609_b4182f27-7ee6-4429-91cc-2dca5d97a119
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA079017
Marketing category
ANDA
Marketing start
2017-12-06
Marketing end
0000-00-00
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
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 packagepackage65841-60965841-609-10DDiscontinued 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
A079017-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16
A079017-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16
A079017-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16
A079017-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16
A079017-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16
A079017-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16
A079017-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A079017-001AB
A079017-002AB
A079017-003AB
A079017-004AB
A079017-005AB
A079017-006AB
A079017-007AB

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 22:54:322026-06A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079017-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-007AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atomoxetineATOMOXETINEZydus Pharmaceuticals USA Inc.5f89c7c9-4c25-4ba2-ad90-5aeadb48f2142025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079017
application number: ANDA079017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-609-10658410609101000 CAPSULE in 1 BOTTLE (65841-609-10) 1000 capsule2017-12-060000-00-00NoNoCurrent