Duloxetine

Product NDC: 65862-453
11-digit product format: 658620453
Labeler code: 65862
Product ID: 65862-453_f64ca39e-f7fc-45e5-a2bf-23b39ada6998
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine Hydrochloride
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090778
Marketing category: ANDA
Marketing start: 2013-12-11
Marketing end: 0000-00-00
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65862-453		D	Discontinued by firm	2026-08-11
excluded package	package	65862-453	65862-453-30	D	Discontinued by firm	2026-08-11
excluded package	package	65862-453	65862-453-39	D	Discontinued by firm	2026-08-11
excluded package	package	65862-453	65862-453-78	D	Discontinued by firm	2026-08-11
excluded package	package	65862-453	65862-453-90	D	Discontinued by firm	2026-08-11
excluded package	package	65862-453	65862-453-99	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 2 · 82 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	65862-453-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-453-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-453-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-453-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-453-99	`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	65862-453-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-453-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-453-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-453-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-453-99	`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	65862-453-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-453-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-453-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-453-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-453-99	`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	65862-453-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-453-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-453-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-453-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-453-99	`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	65862-453-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-453-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-453-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-453-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-453-99	`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	65862-453-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-453-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-453-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-453-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-453-99	`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	65862-453-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-453-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-453-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-453-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-453-99	`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	65862-453-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-453-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-453-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-453-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-453-99	`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	65862-453-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-453-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-453-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-453-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-453-99	`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	65862-453-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-453-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-453-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-453-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-453-99	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090778-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090778-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090778-003	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 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090778-001	AB
A090778-002	AB
A090778-003	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 4 · 123 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	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	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	A090778-001	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	A090778-002	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	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090778-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090778-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090778-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090778-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-453-99	EA - Each	65862-453	424873ab-49d9-450f-a498-822fc680584f	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
METHYLENE CHLORIDE	INACTIVE INGREDIENT	588X2YUY0A	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	5

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx of Tennessee, LLC	afd59273-75cb-5f33-e053-2995a90ab25f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778
Duloxetine	DULOXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	3adfceb3-5f89-4bcf-b874-e3cb572a98b6	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	51c342c9-b9c6-467d-8fea-b73d72e3febc	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	c34f6115-f447-450f-8c83-58f3c51a76c9	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778
Duloxetine	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b102b8e6-d58f-419c-bb35-720bafa13294	2020-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9044SC542W	DULOXETINE HYDROCHLORIDE	136434-34-9	DULOXETINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-453-30	65862045330	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-30)		2013-12-11	0000-00-00	No	No	Current
65862-453-39	65862045339	3000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-39)		2013-12-11	0000-00-00	No	No	Current
65862-453-78	65862045378	10 BLISTER PACK in 1 CARTON (65862-453-78) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-453-10)	10 blister pack	2013-12-11	0000-00-00	No	No	Current
65862-453-90	65862045390	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-90)		2013-12-11	0000-00-00	No	No	Current
65862-453-99	65862045399	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-99)		2013-12-11	0000-00-00	No	No	Current