Home NDC 0904-6908 Atomoxetine
Product NDC 0904-6908
11-digit product format 009046908
Labeler code 0904
Product ID 0904-6908_e4c4122b-6772-46a0-aaaa-3815e6a9736f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA090609
Marketing category ANDA
Marketing start 2018-02-23
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 2026-12-31
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090609-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…2026-08-01 22:54:32 2026-06 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atomoxetine ATOMOXETINE REMEDYREPACK INC. d7002d75-edad-4141-91bf-7eebf50ad1aa 2025-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Major Pharmaceuticals f98c3424-1c43-43e4-8bca-2e3430f50c63 2025-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 0904-6908 Atomoxetine ATOMOXETINE Bryant Ranch Prepack b7f78a37-d525-42b7-813a-fa3e18ae7b74 2023-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Bryant Ranch Prepack 92de0ca1-6a02-4925-aefc-b32573d349a7 2023-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Dr. Reddy's Laboratories Limited 973bdc9b-6421-7e00-e2b6-3cce036d363e 2022-01-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609
Additional Listing Data#
Finished product Yes
Brand name base Atomoxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOMOXETINE HYDROCHLORIDE 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349594 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 0904-6908-04 Atomoxetine 30 in 1 CARTON CAPSULE 30 5 0904-6908-04 Atomoxetine 1 in 1 BLISTER PACK CAPSULE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6908 ATOMOXETINE CAPSULE [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20250330_f98c3424-1c43-43e4-8bca-2e3430f50c63.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 0904-6908-04 00904690804 30 BLISTER PACK in 1 CARTON (0904-6908-04) / 1 CAPSULE in 1 BLISTER PACK 30 blister pack 2018-02-23 0000-00-00 No No Current