atomoxetine

Product NDC: 65841-609
11-digit product format: 658410609
Labeler code: 65841
Product ID: 65841-609_b4182f27-7ee6-4429-91cc-2dca5d97a119
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atomoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA079017
Marketing category: ANDA
Marketing start: 2017-12-06
Marketing end: 0000-00-00
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65841-609		D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-02	D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-06	D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-10	D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-14	D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-16	D	Discontinued by firm	2026-07-31
excluded package	package	65841-609	65841-609-77	D	Discontinued by firm	2026-07-31

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

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
A079017-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079017-001	AB
A079017-002	AB
A079017-003	AB
A079017-004	AB
A079017-005	AB
A079017-006	AB
A079017-007	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A079017-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079017-007	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
atomoxetine	ATOMOXETINE	Zydus Pharmaceuticals USA Inc.	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079017 application number: ANDA079017

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-609-02	65841060902	2000 CAPSULE in 1 BOTTLE (65841-609-02)	2000 capsule	2017-12-06	0000-00-00	No	No	Current
65841-609-06	65841060906	30 CAPSULE in 1 BOTTLE (65841-609-06)	30 capsule	2017-12-06	0000-00-00	No	No	Current
65841-609-10	65841060910	1000 CAPSULE in 1 BOTTLE (65841-609-10)	1000 capsule	2017-12-06	0000-00-00	No	No	Current
65841-609-14	65841060914	60 CAPSULE in 1 BOTTLE (65841-609-14)	60 capsule	2017-12-06	0000-00-00	No	No	Current
65841-609-16	65841060916	90 CAPSULE in 1 BOTTLE (65841-609-16)	90 capsule	2017-12-06	0000-00-00	No	No	Current
65841-609-77	65841060977	10 BLISTER PACK in 1 CARTON (65841-609-77) > 10 CAPSULE in 1 BLISTER PACK (65841-609-30)	10 blister pack	2017-12-06	0000-00-00	No	No	Current