Atomoxetine

Product NDC: 72162-2543
Requested package NDC: 72162-2543-3
11-digit product format: 721622543
Labeler code: 72162
Product ID: 72162-2543_5992e5cd-c1d6-47a1-9a9a-ed2ff4d6f207
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atomoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA079021
Marketing category: ANDA
Marketing start: 2025-07-01
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	Approval date
A079021-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A079021-001	AB
A079021-002	AB
A079021-003	AB
A079021-004	AB
A079021-005	AB
A079021-006	AB
A079021-007	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 7 · 252 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
2026-09-14 22:38:34	2026-08	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079021-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079021-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079021-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079021-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079021-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-005	AB	1	`fd3edfee7708…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb2c12e4-563c-417e-bee1-6d8c51e75af4	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2543-3	Atomoxetine	30 in 1 BOTTLE	CAPSULE	30		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2543-3	EA - Each	72162-2543	0a88c237-cc40-4708-a50c-07a353482a3b	1	2025-12-16

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	47cd1d85-fbc1-4309-9365-58bacf108f5b	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	b00eb367-d7cc-42fa-91af-a1a5f90dbb41	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	bb2c12e4-563c-417e-bee1-6d8c51e75af4	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021 ndc (package): 72162-2543-3 ndc (product): 72162-2543 ndc11 (package): 72162254303
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	c5e9e305-8d99-4234-b531-6ade177768b7	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	1d26aff3-72a7-4a5b-a6fe-44dc8a08b196	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	9c1f858c-8721-49e3-be8b-bf180e89ff42	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	bbb2a8f6-0816-47b1-830a-ef23e97d498f	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	c6542d69-d0a2-4663-9172-943f9f6f5325	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Strides Pharma Science Limited	2614df7e-0b16-4b03-883e-141d4ec34b35	2025-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57WVB6I2W0	ATOMOXETINE HYDROCHLORIDE	82248-59-7	ATOMOXETINE HYDROCHLORIDE
ASW034S0B8	ATOMOXETINE	83015-26-3	Atomoxetine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349593	atomoxetine HCl 25 MG Oral Capsule	PSN	bb2c12e4-563c-417e-bee1-6d8c51e75af4	101
349593	atomoxetine 25 MG Oral Capsule	SCD	bb2c12e4-563c-417e-bee1-6d8c51e75af4	101
349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY	bb2c12e4-563c-417e-bee1-6d8c51e75af4	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2543-3	72162254303	30 CAPSULE in 1 BOTTLE (72162-2543-3)	30 capsule	2025-10-16	No	No	Current