Atomoxetine

Product NDC
66993-045
11-digit product format
669930045
Labeler code
66993
Product ID
66993-045_c4159827-82b0-4cea-a1a0-b86403780f88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021411
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-05-30
Marketing end
2022-01-31
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66993-045DDiscontinued by firm2026-08-17
excluded packagepackage66993-04566993-045-30DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66993-045-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66993-045-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66993-045-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66993-045-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66993-045-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66993-045-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66993-045-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66993-045-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66993-045-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66993-045-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66993-045-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66993-045-30557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021411-001STRATTERAATOMOXETINE HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26
N021411-002STRATTERAATOMOXETINE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-003STRATTERAATOMOXETINE HYDROCHLORIDEEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-004STRATTERAATOMOXETINE HYDROCHLORIDEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-005STRATTERAATOMOXETINE HYDROCHLORIDEEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-006STRATTERAATOMOXETINE HYDROCHLORIDEEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-007STRATTERAATOMOXETINE HYDROCHLORIDEEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14
N021411-008STRATTERAATOMOXETINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14

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 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021411-001STRATTERAEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-002STRATTERAEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-003STRATTERAEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-004STRATTERAEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-005STRATTERAEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-006STRATTERAEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-007STRATTERAEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021411-008STRATTERAEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021411-001STRATTERAEQ 5MG BASECAPSULE / ORAL2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-002STRATTERAEQ 10MG BASECAPSULE / ORALRLD2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-003STRATTERAEQ 18MG BASECAPSULE / ORALRLD2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-004STRATTERAEQ 25MG BASECAPSULE / ORALRLD2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-005STRATTERAEQ 40MG BASECAPSULE / ORALRLD2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-006STRATTERAEQ 60MG BASECAPSULE / ORALRLD2002-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-007STRATTERAEQ 80MG BASECAPSULE / ORALRLD2005-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021411-008STRATTERAEQ 100MG BASECAPSULE / ORALRLD2005-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-001STRATTERAEQ 5MG BASECAPSULE / ORAL2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-002STRATTERAEQ 10MG BASECAPSULE / ORALRLD2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-003STRATTERAEQ 18MG BASECAPSULE / ORALRLD2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-004STRATTERAEQ 25MG BASECAPSULE / ORALRLD2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-005STRATTERAEQ 40MG BASECAPSULE / ORALRLD2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-006STRATTERAEQ 60MG BASECAPSULE / ORALRLD2002-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-007STRATTERAEQ 80MG BASECAPSULE / ORALRLD2005-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021411-008STRATTERAEQ 100MG BASECAPSULE / ORALRLD2005-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021411-001STRATTERAEQ 5MG BASECAPSULE / ORAL2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-002STRATTERAEQ 10MG BASECAPSULE / ORALABRLD2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-003STRATTERAEQ 18MG BASECAPSULE / ORALABRLD2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-004STRATTERAEQ 25MG BASECAPSULE / ORALABRLD2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-005STRATTERAEQ 40MG BASECAPSULE / ORALABRLD2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-006STRATTERAEQ 60MG BASECAPSULE / ORALABRLD, RS2002-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-007STRATTERAEQ 80MG BASECAPSULE / ORALABRLD2005-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-008STRATTERAEQ 100MG BASECAPSULE / ORALABRLD2005-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-001STRATTERAEQ 5MG BASECAPSULE / ORAL2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-002STRATTERAEQ 10MG BASECAPSULE / ORALABRLD2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-003STRATTERAEQ 18MG BASECAPSULE / ORALABRLD2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-004STRATTERAEQ 25MG BASECAPSULE / ORALABRLD2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-005STRATTERAEQ 40MG BASECAPSULE / ORALABRLD2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-006STRATTERAEQ 60MG BASECAPSULE / ORALABRLD, RS2002-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-007STRATTERAEQ 80MG BASECAPSULE / ORALABRLD2005-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-008STRATTERAEQ 100MG BASECAPSULE / ORALABRLD2005-02-14fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N021411-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021411-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021411-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021411-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021411-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-006AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-007AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021411-008AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021411-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021411-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021411-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021411-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021411-006AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-045-30EA - Each66993-0456cd22069-ab14-4ab9-ac46-2e31d79db73f12017-06-15

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
StratteraATOMOXETINE HYDROCHLORIDEEli Lilly and Company309de576-c318-404a-bc15-660c2b1876fb2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021411
application number: NDA021411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-045-306699300453030 CAPSULE in 1 BOTTLE (66993-045-30) 30 capsule2017-05-300000-00-00NoNoCurrent