ATOMOXETINE CAPSULES

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#

Productatomoxetine
Active ingredientATOMOXETINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-606-16 in bottle of 90 Capsules

Atomoxetine Capsules, 18 mg

90 Capsules

Atomoxetine 18 mg
Atomoxetine 18 mg

NDC 65841-607-16 in bottle of 90 Capsules

Atomoxetine Capsules, 25 mg

90 Capsules

Atomoxetine 25 mg
Atomoxetine 25 mg

NDC 65841-608-16 in bottle of 90 Capsules

Atomoxetine Capsules, 40 mg

90 Capsules

Atomoxetine 40 mg
Atomoxetine 40 mg

NDC 65841-609-16 in bottle of 90 Capsules

Atomoxetine Capsules, 60 mg

90 Capsules

Atomoxetine 60 mg
Atomoxetine 60 mg

NDC 65841-610-16 in bottle of 90 Capsules

Atomoxetine Capsules, 80 mg

90 Capsules

Atomoxetine 80 mg
Atomoxetine 80 mg

NDC 65841-611-16 in bottle of 90 Capsules

Atomoxetine Capsules, 100 mg

90 Capsules

Atomoxetine caps 100 mg
Atomoxetine caps 100 mg

NDC 65841-605-16 in bottle of 90 Capsules

Atomoxetine Capsules, 10 mg

90 Capsules

10 mg label
10 mg label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 83 matching rows.

Source Document#

Source XML

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-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.

Product history page 1 of 8 · 283 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 283 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079017-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A079017-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A079017-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079017-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079017-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079017-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079017-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079017-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079017-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-005AB1fd3edfee7708…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9b7524bf-8d70-4455-8824-61160cc97e892e3dffc9-90f2-443c-88e5-e8a9bf1ba1432025-03-21Exact identifier
spl set id: 2e3dffc9-90f2-443c-88e5-e8a9bf1ba143

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.