Home DailyMed 2e3dffc9-90f2-443c-88e5-e8a9bf1ba143 ATOMOXETINE CAPSULES Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2024-11-25
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 7
Source legacy-cache
Hydrated at 2026-08-01 20:48:37 Label at a glance# Product atomoxetine
Active ingredient ATOMOXETINE HYDROCHLORIDE
Label structure 1 sections
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 16 matching rows.
atomoxetine ATOMOXETINE HYDROCHLORIDE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE FD&C BLUE NO. 2 FERRIC OXIDE RED AMMONIA WATER NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 65841-605 65841-605-06 , 65841-605-16 , 65841-605-14 , 65841-605-10 , 65841-605-02 , 65841-605-30 , 65841-605-77 65841-606 65841-606-06 , 65841-606-14 , 65841-606-16 , 65841-606-10 , 65841-606-02 65841-607 65841-607-06 , 65841-607-14 , 65841-607-16 , 65841-607-10 , 65841-607-02 , 65841-607-30 , 65841-607-77 65841-608 65841-608-06 , 65841-608-14 , 65841-608-16 , 65841-608-10 , 65841-608-02 , 65841-608-30 , 65841-608-77 65841-609 65841-609-06 , 65841-609-14 , 65841-609-16 , 65841-609-10 , 65841-609-02 , 65841-609-30 , 65841-609-77 65841-610 65841-610-06 , 65841-610-14 , 65841-610-16 , 65841-610-10 , 65841-610-02 , 65841-610-30 , 65841-610-77 65841-611 65841-611-14 , 65841-611-10 , 65841-611-02 , 65841-611-06 , 65841-611-16
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 3 · 83 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 8 · 283 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 2026-09-14 22:38:34 2026-08 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 283 observed states.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.