Home NDC 49999-636 Strattera
Product NDC 49999-636
11-digit product format 499990636
Labeler code 49999
Product ID 49999-636_5f48f6d9-92c0-4437-b354-5cbe1ac225cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application NDA021411
Marketing category NDA
Marketing start 2010-07-13
Marketing end 0000-00-00
Substance ATOMOXETINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49999-636-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49999-636-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49999-636-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49999-636-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49999-636-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49999-636-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49999-636-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49999-636-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49999-636-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49999-636-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49999-636-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49999-636-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49999-636-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49999-636-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49999-636-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49999-636-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 49999-636-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 49999-636-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 49999-636-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 49999-636-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 49999-636-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49999-636-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021411-001 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 N021411-002 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-003 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-004 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-005 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-006 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-007 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14 N021411-008 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021411-001 STRATTERA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-002 STRATTERA EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-003 STRATTERA EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-004 STRATTERA EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-005 STRATTERA EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-006 STRATTERA EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-007 STRATTERA EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021411-008 STRATTERA EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021411-001 STRATTERA EQ 5MG BASE CAPSULE / ORAL 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-002 STRATTERA EQ 10MG BASE CAPSULE / ORAL RLD 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-003 STRATTERA EQ 18MG BASE CAPSULE / ORAL RLD 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-004 STRATTERA EQ 25MG BASE CAPSULE / ORAL RLD 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-005 STRATTERA EQ 40MG BASE CAPSULE / ORAL RLD 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-006 STRATTERA EQ 60MG BASE CAPSULE / ORAL RLD 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-007 STRATTERA EQ 80MG BASE CAPSULE / ORAL RLD 2005-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021411-008 STRATTERA EQ 100MG BASE CAPSULE / ORAL RLD 2005-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-001 STRATTERA EQ 5MG BASE CAPSULE / ORAL 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-002 STRATTERA EQ 10MG BASE CAPSULE / ORAL RLD 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-003 STRATTERA EQ 18MG BASE CAPSULE / ORAL RLD 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-004 STRATTERA EQ 25MG BASE CAPSULE / ORAL RLD 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-005 STRATTERA EQ 40MG BASE CAPSULE / ORAL RLD 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-006 STRATTERA EQ 60MG BASE CAPSULE / ORAL RLD 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-007 STRATTERA EQ 80MG BASE CAPSULE / ORAL RLD 2005-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021411-008 STRATTERA EQ 100MG BASE CAPSULE / ORAL RLD 2005-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021411-001 STRATTERA EQ 5MG BASE CAPSULE / ORAL 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-002 STRATTERA EQ 10MG BASE CAPSULE / ORAL AB RLD 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-003 STRATTERA EQ 18MG BASE CAPSULE / ORAL AB RLD 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-004 STRATTERA EQ 25MG BASE CAPSULE / ORAL AB RLD 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-005 STRATTERA EQ 40MG BASE CAPSULE / ORAL AB RLD 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-006 STRATTERA EQ 60MG BASE CAPSULE / ORAL AB RLD, RS 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-007 STRATTERA EQ 80MG BASE CAPSULE / ORAL AB RLD 2005-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021411-008 STRATTERA EQ 100MG BASE CAPSULE / ORAL AB RLD 2005-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-001 STRATTERA EQ 5MG BASE CAPSULE / ORAL 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-002 STRATTERA EQ 10MG BASE CAPSULE / ORAL AB RLD 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-003 STRATTERA EQ 18MG BASE CAPSULE / ORAL AB RLD 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-004 STRATTERA EQ 25MG BASE CAPSULE / ORAL AB RLD 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-005 STRATTERA EQ 40MG BASE CAPSULE / ORAL AB RLD 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-006 STRATTERA EQ 60MG BASE CAPSULE / ORAL AB RLD, RS 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-007 STRATTERA EQ 80MG BASE CAPSULE / ORAL AB RLD 2005-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021411-008 STRATTERA EQ 100MG BASE CAPSULE / ORAL AB RLD 2005-02-14 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 266 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Strattera ATOMOXETINE HYDROCHLORIDE Eli Lilly and Company 309de576-c318-404a-bc15-660c2b1876fb 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021411 application number: NDA021411