Home NDC 0002-3251 Strattera
Product NDC 0002-3251
11-digit product format 000023251
Labeler code 0002
Product ID 0002-3251_8360d9e6-0df4-4969-9efa-7c01e69d6947
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Eli Lilly and Company
Application NDA021411
Marketing category NDA
Marketing start 2005-02-14
Marketing end 2027-07-31
Substance ATOMOXETINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes 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STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 2002-11-26 N021411-002 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-003 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-004 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-005 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-006 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2002-11-26 N021411-007 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-02-14 N021411-008 STRATTERA ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE **Federal Register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 ndc (product): 0002-3251
Additional Listing Data#
Finished product Yes
Brand name base Strattera Active Ingredients# Ingredient, Strength table Ingredient Strength ATOMOXETINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WVB6I2W0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 14 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349591 Internal RxNorm lookup 349592 Internal RxNorm lookup 349593 Internal RxNorm lookup 349594 Internal RxNorm lookup 349595 Internal RxNorm lookup 352317 Internal RxNorm lookup 352318 Internal RxNorm lookup 352319 Internal RxNorm lookup 352320 Internal RxNorm lookup 352321 Internal RxNorm lookup 608139 Internal RxNorm lookup 608143 Internal RxNorm lookup 617945 Internal RxNorm lookup 617947 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-3251-30 Strattera 30 in 1 BOTTLE CAPSULE 30 66
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-3251 STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY
] 65 Current NDC, Legacy NDC, 1 package rows 20241115_309de576-c318-404a-bc15-660c2b1876fb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0002-3251-30 00002325130 30 CAPSULE in 1 BOTTLE (0002-3251-30) 30 capsule 2005-08-24 2027-07-31 No No Current