Atomoxetine

Product NDC
0904-6908
11-digit product format
009046908
Labeler code
0904
Product ID
0904-6908_e4c4122b-6772-46a0-aaaa-3815e6a9736f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090609
Marketing category
ANDA
Marketing start
2018-02-23
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090609-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23
A090609-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23
A090609-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23
A090609-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23
A090609-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23
A090609-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23
A090609-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090609-001AB
A090609-002AB
A090609-003AB
A090609-004AB
A090609-005AB
A090609-006AB
A090609-007AB

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 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090609-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090609-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090609-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090609-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090609-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090609-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090609-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090609-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090609-005AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57WVB6I2W0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349594Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f98c3424-1c43-43e4-8bca-2e3430f50c63Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6908-04Atomoxetine30 in 1 CARTONCAPSULE305
0904-6908-04Atomoxetine1 in 1 BLISTER PACKCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6908-04EA - Each0904-6908ba3734b2-c3eb-4c7a-a818-f4207c66768d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6908ATOMOXETINE CAPSULE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250330_f98c3424-1c43-43e4-8bca-2e3430f50c63.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINEREMEDYREPACK INC.d7002d75-edad-4141-91bf-7eebf50ad1aa2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEMajor Pharmaceuticalsf98c3424-1c43-43e4-8bca-2e3430f50c632025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
ndc (product): 0904-6908
AtomoxetineATOMOXETINEBryant Ranch Prepackb7f78a37-d525-42b7-813a-fa3e18ae7b742023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEBryant Ranch Prepack92de0ca1-6a02-4925-aefc-b32573d349a72023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEDr. Reddy's Laboratories Limited973bdc9b-6421-7e00-e2b6-3cce036d363e2022-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNf98c3424-1c43-43e4-8bca-2e3430f50c635
349594atomoxetine 40 MG Oral CapsuleSCDf98c3424-1c43-43e4-8bca-2e3430f50c635
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYf98c3424-1c43-43e4-8bca-2e3430f50c635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6908-040090469080430 BLISTER PACK in 1 CARTON (0904-6908-04) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2018-02-230000-00-00NoNoCurrent