Strattera

Product NDC: 64725-3228
11-digit product format: 647253228
Labeler code: 64725
Product ID: 64725-3228_418efa18-077c-43db-9b9a-ce25d59d4e10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atomoxetine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: NDA021411
Marketing category: NDA
Marketing start: 2003-01-10
Marketing end: 0000-00-00
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	64725-3228		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-3228	64725-3228-1	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-3228-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-3228-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-3228-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-3228-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-3228-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-3228-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-3228-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-3228-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-3228-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-3228-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64725-3228-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64725-3228-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-3228-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-3228-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-3228-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-3228-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-3228-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-3228-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-3228-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-3228-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-3228-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-3228-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021411-001	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		2002-11-26
N021411-002	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-003	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-004	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-005	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-006	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-007	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14
N021411-008	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14

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 9 · 328 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
2026-02-19 14:30 UTC	2026-02	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021411-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-006	AB	1	`5bbf6a4d5a75…`

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
64725-3228-1	2020-01-31	C162847	48780-1	9d75b9d0-e8fc-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA. STRATTERA (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
64725-3228-1	Strattera	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atomoxetine hydrochloride	ACTIVE INGREDIENT	57WVB6I2W0	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
Atomoxetine	ACTIVE MOIETY	ASW034S0B8	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-3228	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20141025_fd1c71bc-1445-4ac6-8a8d-79050e61b03a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Strattera	ATOMOXETINE HYDROCHLORIDE	Eli Lilly and Company	309de576-c318-404a-bc15-660c2b1876fb	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021411 application number: NDA021411

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
349593	atomoxetine HCl 25 MG Oral Capsule	PSN	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2
352319	Strattera 25 MG Oral Capsule	PSN	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2
352319	atomoxetine 25 MG Oral Capsule [Strattera]	SBD	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2
349593	atomoxetine 25 MG Oral Capsule	SCD	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2
349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2
352319	Strattera 25 MG Oral Capsule	SY	fd1c71bc-1445-4ac6-8a8d-79050e61b03a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-3228-1	64725322801	30 in 1 BOTTLE	Historical