Duloxetine

Product NDC: 68084-692
11-digit product format: 680840692
Labeler code: 68084
Product ID: 68084-692_e9ae690d-2624-1ef5-e053-2a95a90a0c30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA090694
Marketing category: ANDA
Marketing start: 2013-12-17
Marketing end: 0000-00-00
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68084-692		D	Discontinued by firm		2026-08-11
excluded package	package	68084-692	68084-692-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-692-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-692-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-692-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-692-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-692-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-692-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-692-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-692-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-692-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-692-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-692-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-692-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090694-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090694-001	AB
A090694-002	AB
A090694-003	AB
A090694-004	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 · 164 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	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-692-01	EA - Each	68084-692	4cd41f0e-9b0c-4f75-9d44-c980f72b37ce	1	2014-01-04
68084-692-11	EA - Each	68084-692	1f30a706-d920-4cc3-bb27-f517e0602f66	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	4

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	REMEDYREPACK INC.	461d769c-b787-4bc7-b4a6-7a5f33ae9d45	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	79e1a9b1-e084-48b6-a252-97bbd2f55a79	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Golden State Medical Supply, Inc.	569582d5-cb6d-735e-e063-6394a90abfb6	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	REMEDYREPACK INC.	c66fb2ee-f64a-4d28-a692-e8dc7b61fbc9	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	REMEDYREPACK INC.	1d3a45f3-3854-4d0c-9241-770aa24063fd	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Lupin Pharmaceuticals, Inc.	829a4f51-c882-4b64-81f3-abfb03a52ebe	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	c877bb68-759f-4d45-8bef-872554da4551	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	QPharma, Inc.	4f205401-39ac-7009-e063-6394a90aaa8c	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	9141b9d3-8d4d-43ec-acf9-e1b620590c4b	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	3424a326-9543-44f7-b31c-f84e12509238	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	cdd870a9-3bed-42fc-b175-48aed5321969	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	ae381859-be09-43e1-8b56-d0d8f4b49020	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Coupler LLC	3edce3bd-1102-5951-e063-6394a90ae6c5	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Coupler LLC	3f649b01-0969-cc71-e063-6394a90a9df5	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	e2352870-3582-4d92-8712-87ad8bdccb87	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	e0381ead-d8bc-43fa-9f12-e0fefcaf7f3d	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Aphena Pharma Solutions - Tennessee, LLC	41c54fb7-03f8-2326-e063-6394a90a6352	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine D/R	DULOXETINE D/R	Direct_Rx	3ac53025-8a99-31de-e063-6294a90a53d2	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	5584c5ed-cab6-4c8b-8307-41e5d77704d0	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	be0261c7-fb5e-4ba6-b7fb-13a1fecb5f75	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9044SC542W	DULOXETINE HYDROCHLORIDE	136434-34-9	DULOXETINE HYDROCHLORIDE
O5TNM5N07U	DULOXETINE	116539-59-4	Duloxetine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-692-01	68084069201	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-692-01) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (68084-692-11)	100 blister pack	2013-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	American Health Packaging	2023-04-28	HUMAN PRESCRIPTION DRUG LABEL	12
Duloxetine	Cardinal Health 107, LLC	2022-11-22	HUMAN PRESCRIPTION DRUG LABEL	11