Atomoxetine Hydrochloride

Product NDC: 70518-4313
11-digit product format: 705184313
Labeler code: 70518
Product ID: 70518-4313_5aa8f613-c6bb-7117-e063-6294a90a0962
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atomoxetine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078983
Marketing category: ANDA
Marketing start: 2025-03-19
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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 · 301 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	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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 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	A078983-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078983-007	AB	1	`84e616aacf4f…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATOMOXETINE HYDROCHLORIDE	10 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
349591	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
6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	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
70518-4313-0	Atomoxetine Hydrochloride	30 in 1 BOX	CAPSULE	30		3
70518-4313-1	Atomoxetine Hydrochloride	1 in 1 POUCH	CAPSULE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4313	ATOMOXETINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	1	Current NDC, 2 package rows	20250322_6d7ea8f7-981c-4acc-aeaf-7516325bfc0c.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	REMEDYREPACK INC.	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	2026-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983 ndc (product): 70518-4313
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	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
349591	atomoxetine HCl 10 MG Oral Capsule	PSN	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	3
349591	atomoxetine 10 MG Oral Capsule	SCD	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	3
349591	atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4313-0	70518431300	30 POUCH in 1 BOX (70518-4313-0) / 1 CAPSULE in 1 POUCH (70518-4313-1)	30 pouch	2025-03-19	No	No	Current
70518-4313-1	70518431301	1 in 1 POUCH					Historical