Home NDC 50090-4236 Atomoxetine Hydrochloride
Product NDC 50090-4236
11-digit product format 500904236
Labeler code 50090
Product ID 50090-4236_d1a130e7-3cee-40cf-a4c6-cb3893304987
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atomoxetine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078983
Marketing category ANDA
Marketing start 2018-05-21
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 44 .
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 A078983-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 A078983-007 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 · 308 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 2026-10-15 13:18:30 2026-09 A078983-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078983-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078983-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078983-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078983-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078983-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078983-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078983-007 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 A078983-001 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 A078983-002 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 A078983-003 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 A078983-004 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 A078983-005 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 A078983-006 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 A078983-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2017-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078983-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078983-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078983-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078983-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078983-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-05-30 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 8 · 308 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 Hydrochloride
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4236-0 Atomoxetine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4236 ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 7 Current NDC, Legacy NDC, 1 package rows 20230208_19b10860-aa08-4480-816c-c207819e5f9e.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 Hydrochloride ATOMOXETINE HYDROCHLORIDE REMEDYREPACK INC. 6d7ea8f7-981c-4acc-aeaf-7516325bfc0c 2026-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078983 application number: ANDA078983 Atomoxetine Hydrochloride ATOMOXETINE HYDROCHLORIDE Apotex Corp. 132852a6-5bff-15dd-255c-98309dd83630 2026-08-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078983 application number: ANDA078983 Atomoxetine Hydrochloride ATOMOXETINE HYDROCHLORIDE AvPAK 9e787cc2-5d0f-f231-e053-2a95a90ae99a 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078983 application number: ANDA078983 Atomoxetine Hydrochloride ATOMOXETINE HYDROCHLORIDE AvPAK a9df4617-b406-70ba-e053-2995a90a28e8 2025-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078983 application number: ANDA078983 Atomoxetine Hydrochloride ATOMOXETINE HYDROCHLORIDE A-S Medication Solutions 19b10860-aa08-4480-816c-c207819e5f9e 2023-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078983 application number: ANDA078983 ndc (product): 50090-4236
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 50090-4236-0 50090423600 30 CAPSULE in 1 BOTTLE (50090-4236-0) 30 capsule 2019-03-29 0000-00-00 No No Current