Atomoxetine

Product NDC: 65862-244
Requested package NDC: 65862-244-15
11-digit product format: 658620244
Labeler code: 65862
Product ID: 65862-244_48d5f73a-bdcc-466a-aa17-53c0a38c3b3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atomoxetine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA079016
Marketing category: ANDA
Marketing start: 2017-05-30
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 100 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

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
unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 21 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-244	65862-244-15	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A079016-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-007	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
A079016-001	AB
A079016-002	AB
A079016-003	AB
A079016-004	AB
A079016-005	AB
A079016-006	AB
A079016-007	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 · 287 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
2026-02-19 14:30 UTC	2026-02	A079016-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-007	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	A079016-001	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	A079016-002	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	A079016-003	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	A079016-004	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	A079016-005	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	A079016-006	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	A079016-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079016-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-007	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	A079016-001	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	A079016-002	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	A079016-003	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	A079016-004	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	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079016-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079016-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079016-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079016-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079016-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079016-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079016-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079016-005	AB	1	`03ed91905a0d…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine	ATOMOXETINE	American Health Packaging	10d36b32-0202-4c03-8a1a-cd5d53f231e7	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	35b42f0c-a183-478b-bced-652dc12b33ec	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Aurobindo Pharma Limited	6f6bea0c-297b-43ff-8960-ecc11243e06e	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016 ndc (product): 65862-244
Atomoxetine	ATOMOXETINE	Rising Pharma Holdings, Inc.	1cceab35-dc4a-40bc-a245-10b64820e217	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	50a20478-5f33-4ecd-b5d3-dbba855e5f6b	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	d4fe9217-1853-4f8b-9a93-77e511554ca1	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	24bb7238-7e12-48d1-a572-2c753e69f604	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	ffdcc267-d6ae-41ee-97d9-2c7596545ce8	2023-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016

Additional Listing Data#

Finished product: Yes
Brand name base: Atomoxetine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATOMOXETINE HYDROCHLORIDE	100 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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349591	Internal RxNorm lookup
349592	Internal RxNorm lookup
349593	Internal RxNorm lookup
349594	Internal RxNorm lookup
349595	Internal RxNorm lookup
608139	Internal RxNorm lookup
608143	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
6f6bea0c-297b-43ff-8960-ecc11243e06e	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
65862-244-05	Atomoxetine	500 in 1 BOTTLE	CAPSULE	500		16
65862-244-30	Atomoxetine	30 in 1 BOTTLE	CAPSULE	30		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-244	ATOMOXETINE CAPSULE [AUROBINDO PHARMA LIMITED]	15	Current NDC, Legacy NDC, 2 package rows	20240215_6f6bea0c-297b-43ff-8960-ecc11243e06e.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	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608139	atomoxetine HCl 100 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349592	atomoxetine HCl 18 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349593	atomoxetine HCl 25 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349594	atomoxetine HCl 40 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349595	atomoxetine HCl 60 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608143	atomoxetine HCl 80 MG Oral Capsule	PSN	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349591	atomoxetine 10 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608139	atomoxetine 100 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349592	atomoxetine 18 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349593	atomoxetine 25 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349594	atomoxetine 40 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349595	atomoxetine 60 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608143	atomoxetine 80 MG Oral Capsule	SCD	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349591	atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608139	atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349592	atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349594	atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
349595	atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16
608143	atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6f6bea0c-297b-43ff-8960-ecc11243e06e	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-244-15	65862024415	1500 CAPSULE in 1 BAG (65862-244-15)	1500 capsule	30-MAY-17	Current