atomoxetine

Product NDC
68382-223
Requested package NDC
68382-223-16
11-digit product format
683820223
Labeler code
68382
Product ID
68382-223_ffa27721-74b3-4ad8-b4c3-8aa29c67861c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-22368382-223-16DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-22368382-223-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-22368382-223-16DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…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-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 7 · 269 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-1603ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 269 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079017-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079017-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079017-005AB103ed91905a0d…

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
68382-223-02atomoxetine2000 in 1 BOTTLECAPSULE20006
68382-223-06atomoxetine30 in 1 BOTTLECAPSULE306
68382-223-10atomoxetine1000 in 1 BOTTLECAPSULE10006
68382-223-14atomoxetine60 in 1 BOTTLECAPSULE606
68382-223-16atomoxetine90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-223ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]6Legacy NDC, 5 package rows20250326_5f89c7c9-4c25-4ba2-ad90-5aeadb48f214.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 · 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
ndc (package): 68382-223-16
ndc (product): 68382-223
ndc11 (package): 68382022316

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine HCl 100 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine HCl 18 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine HCl 25 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine HCl 40 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine HCl 60 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine HCl 80 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-223-166838202231690 CAPSULE in 1 BOTTLE (68382-223-16) 90 capsule2017-12-060000-00-00NoNoCurrent