Home DailyMed 879dd29c-8fc4-4d65-99b1-7ddd7121b9ec National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:11:26 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 N021411-002 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-003 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-004 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-005 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-006 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-007 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE **Federal Register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 · 344 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 2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 266 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.