Atomoxetine Hydrochloride

Product NDC: 50090-4243
11-digit product format: 500904243
Labeler code: 50090
Product ID: 50090-4243_3f82534e-1d3b-4707-a042-5832b649d7a8
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
Marketing end: 0000-00-00
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 80 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4243		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-4243	50090-4243-0	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4243-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4243-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4243-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4243-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4243-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4243-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4243-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4243-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4243-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4243-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4243-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4243-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4243-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4243-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4243-0	`1332a3947898…`	`d4bfe170f9cd…`

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	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.

Application-product, TE code table
Application-product	TE code
A078983-001	AB
A078983-002	AB
A078983-003	AB
A078983-004	AB
A078983-005	AB
A078983-006	AB
A078983-007	AB

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 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2025-08-23 18:47 UTC	2025-08	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-007	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	A078983-001	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	A078983-002	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	A078983-003	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	A078983-004	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	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078983-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078983-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078983-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-005	AB	1	`b8a1b40f171c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d16f546-db6a-1939-50fc-d06382424c97	Product name	4	20210903

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4243-0	2023-01-30	C162847	48780-1	f386c649-e092-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4243-0	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
50090-4243	ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 1 package rows	20210617_8b7637ba-0541-41ef-bb54-1940fbbb8c64.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	6f14ced9-c16c-905a-e053-2a91aa0a031e	2025-05-28	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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57WVB6I2W0	ATOMOXETINE HYDROCHLORIDE	82248-59-7	ATOMOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
608143	atomoxetine HCl 80 MG Oral Capsule	PSN	8b7637ba-0541-41ef-bb54-1940fbbb8c64	7
608143	atomoxetine 80 MG Oral Capsule	SCD	8b7637ba-0541-41ef-bb54-1940fbbb8c64	7
608143	atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule	SY	8b7637ba-0541-41ef-bb54-1940fbbb8c64	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4243-0	50090424300	30 CAPSULE in 1 BOTTLE (50090-4243-0)	30 capsule	2019-03-29	0000-00-00	No	No	Current