Home NDC 50090-6143 Atomoxetine
Product NDC 50090-6143
11-digit product format 500906143
Labeler code 50090
Product ID 50090-6143_a726ffd7-e7bd-4005-8b8a-b4d9bb58b67f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA202682
Marketing category ANDA
Marketing start 2021-03-11
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 42 .
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 A202682-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 A202682-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 A202682-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 A202682-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 A202682-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB RS 2021-03-11 A202682-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 A202682-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11
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.
Product history page 1 of 7 · 245 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 2026-08-18 06:07:40 2026-07 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB RS 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202682-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB RS 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202682-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB RS 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202682-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202682-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202682-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2021-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202682-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2021-03-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202682-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2021-03-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202682-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2021-03-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202682-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2021-03-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202682-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2021-03-11 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 245 observed states.
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 50090-6143-0 Atomoxetine 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6143 ATOMOXETINE (ATOMOXETINE) CAPSULE [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 1 package rows 20231102_0782204e-56a3-4439-9fb8-194da9487049.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 Camber Pharmaceuticals, Inc. f266ab7b-5a68-42b5-b204-e3249bea0aed 2026-05-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202682 application number: ANDA202682 Atomoxetine ATOMOXETINE A-S Medication Solutions 652cb30f-4368-4009-93a3-3a0d2a365f42 2026-02-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202682 application number: ANDA202682 Atomoxetine ATOMOXETINE NorthStar RxLLC 14f2804d-2914-4dd9-86c0-d084fcfd7e50 2026-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202682 application number: ANDA202682 Atomoxetine ATOMOXETINE A-S Medication Solutions 14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202682 application number: ANDA202682 Atomoxetine ATOMOXETINE A-S Medication Solutions 0782204e-56a3-4439-9fb8-194da9487049 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202682 application number: ANDA202682 ndc (product): 50090-6143
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 50090-6143-0 50090614300 30 CAPSULE in 1 BOTTLE (50090-6143-0) 30 capsule 2022-10-04 0000-00-00 No No Current