Home NDC 65841-611-10 atomoxetine
Product NDC 65841-611
Requested package NDC 65841-611-10
11-digit product format 658410611
Labeler code 65841
Product ID 65841-611_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 100 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65841-611 65841-611-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65841-611 65841-611-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079017-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 7 · 269 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 269 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join atomoxetine ATOMOXETINE Zydus Pharmaceuticals USA Inc. 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 2025-03-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079017 application number: ANDA079017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65841-611-10 65841061110 1000 CAPSULE in 1 BOTTLE (65841-611-10) 1000 capsule 2017-12-06 0000-00-00 No No Current