Home NDC 50090-6512 Atomoxetine
Product NDC 50090-6512
11-digit product format 500906512
Labeler code 50090
Product ID 50090-6512_1f10d97d-94f3-4f0a-8332-df2d5fb95b0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA079022
Marketing category ANDA
Marketing start 2017-05-30
Substance ATOMOXETINE HYDROCHLORIDE
Active strength 25 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 43 .
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 A079022-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 A079022-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30
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 8 · 301 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 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079022-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079022-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079022-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079022-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079022-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079022-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079022-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079022-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079022-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079022-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 301 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atomoxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOMOXETINE HYDROCHLORIDE 25 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 349593 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 50090-6512-0 Atomoxetine 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6512 ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20230608_402711d7-bd44-4f2a-ad2b-4756cdc68645.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 AvKARE dc7ba02c-bdbb-5136-e053-2995a90ac545 2026-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079022 application number: ANDA079022 Atomoxetine ATOMOXETINE A-S Medication Solutions ddec2943-483d-403a-838c-cbdb6eefe0a1 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079022 application number: ANDA079022 Atomoxetine ATOMOXETINE A-S Medication Solutions 96855061-440f-4c99-a152-cf8da8e2b1b3 2023-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079022 application number: ANDA079022 Atomoxetine ATOMOXETINE A-S Medication Solutions aa109260-6d4c-429c-9957-19cbe0e34485 2023-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079022 application number: ANDA079022 Atomoxetine ATOMOXETINE A-S Medication Solutions 402711d7-bd44-4f2a-ad2b-4756cdc68645 2023-06-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079022 application number: ANDA079022 ndc (product): 50090-6512
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6512-0 50090651200 30 CAPSULE in 1 BOTTLE (50090-6512-0) 30 capsule 2023-06-01 No No Current