atomoxetine

Product NDC: 68382-216
Requested package NDC: 68382-216-14
11-digit product format: 683820216
Labeler code: 68382
Product ID: 68382-216_ffa27721-74b3-4ad8-b4c3-8aa29c67861c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atomoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA079017
Marketing category: ANDA
Marketing start: 2017-12-06
Marketing end: 0000-00-00
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 18 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68382-216	68382-216-14	D	Discontinued by firm		2026-08-03

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.

Product history page 1 of 5 · 185 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
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-001	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-002	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-003	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-004	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-005	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-006	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2010-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079017-001	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-002	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-003	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-004	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-005	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-006	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2010-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079017-001	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-002	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-003	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-004	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-005	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-006	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2010-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079017-001	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-002	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-003	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-004	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-005	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-006	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2010-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079017-001	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2010-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079017-002	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2010-09-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-006	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079017-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079017-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-006	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079017-007	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079017-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079017-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079017-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079017-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079017-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079017-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079017-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079017-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079017-002	AB	1	`bb7c543d1eb4…`

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 ndc (package): 68382-216-14 ndc (product): 68382-216 ndc11 (package): 68382021614

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	SPL version
68382-216-02	atomoxetine	2000 in 1 BOTTLE	CAPSULE	2000	6
68382-216-06	atomoxetine	30 in 1 BOTTLE	CAPSULE	30	6
68382-216-10	atomoxetine	1000 in 1 BOTTLE	CAPSULE	1000	6
68382-216-14	atomoxetine	60 in 1 BOTTLE	CAPSULE	60	6
68382-216-16	atomoxetine	90 in 1 BOTTLE	CAPSULE	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-216	ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]	6	Legacy NDC, 5 package rows	20250326_5f89c7c9-4c25-4ba2-ad90-5aeadb48f214.zip

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
349591	atomoxetine HCl 10 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608139	atomoxetine HCl 100 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349592	atomoxetine HCl 18 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349593	atomoxetine HCl 25 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349594	atomoxetine HCl 40 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349595	atomoxetine HCl 60 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608143	atomoxetine HCl 80 MG Oral Capsule	PSN	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349591	atomoxetine 10 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608139	atomoxetine 100 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349592	atomoxetine 18 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349593	atomoxetine 25 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349594	atomoxetine 40 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349595	atomoxetine 60 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608143	atomoxetine 80 MG Oral Capsule	SCD	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349591	atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608139	atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349592	atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349594	atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
349595	atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6
608143	atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule	SY	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-216-14	68382021614	60 CAPSULE in 1 BOTTLE (68382-216-14)	60 capsule	2017-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
atomoxetine	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	6