Home NDC 66993-043 Atomoxetine
Product NDC 66993-043
11-digit product format 669930043
Labeler code 66993
Product ID 66993-043_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 2022-03-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 N021411-002 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-003 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-004 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-005 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-006 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-007 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14 N021411-008 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE **Federal Register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.
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 2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…
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 66993-043-30 66993004330 30 CAPSULE in 1 BOTTLE (66993-043-30) 30 capsule 2017-05-30 0000-00-00 No No Current