Home NDC 66993-046-30 Atomoxetine
Product NDC 66993-046
Requested package NDC 66993-046-30
11-digit product format 669930046
Labeler code 66993
Product ID 66993-046_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 100 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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 2 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66993-046 66993-046-30 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66993-046 66993-046-30 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 N021411-002 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-003 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register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 · 328 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 2026-02-19 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-001 STRATTERA EQ 5MG BASE CAPSULE / ORAL 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-002 STRATTERA EQ 10MG BASE CAPSULE / ORAL AB RLD 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-003 STRATTERA EQ 18MG BASE CAPSULE / ORAL AB RLD 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-004 STRATTERA EQ 25MG BASE CAPSULE / ORAL AB RLD 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-005 STRATTERA EQ 40MG BASE CAPSULE / ORAL AB RLD 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-006 STRATTERA EQ 60MG BASE CAPSULE / ORAL AB RLD, RS 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-007 STRATTERA EQ 80MG BASE CAPSULE / ORAL AB RLD 2005-02-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021411-008 STRATTERA EQ 100MG BASE CAPSULE / ORAL AB RLD 2005-02-14 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 266 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66993-046-30 66993004630 30 CAPSULE in 1 BOTTLE (66993-046-30) 30 capsule 2017-05-30 2022-01-31 No No Current