Duloxetine

Product NDC: 68001-257
11-digit product format: 680010257
Labeler code: 68001
Product ID: 68001-257_c7179eef-e09a-2f0f-e053-2995a90a6309
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA090739
Marketing category: ANDA
Marketing start: 2014-03-14
Marketing end: 2021-11-30
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68001-257		D	Discontinued by firm	2026-09-14
excluded package	package	68001-257	68001-257-04	D	Discontinued by firm	2026-09-14
excluded package	package	68001-257	68001-257-08	D	Discontinued by firm	2026-09-14

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 · 36 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	68001-257-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-257-04	`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	68001-257-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-257-04	`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	68001-257-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-257-04	`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	68001-257-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-257-04	`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	68001-257-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-257-04	`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	68001-257-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-257-04	`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	68001-257-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-257-04	`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	68001-257-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-257-04	`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	68001-257-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-257-04	`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	68001-257-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-257-04	`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	68001-257-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-257-04	`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	68001-257-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-257-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090739-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090739-001	AB
A090739-002	AB
A090739-003	AB
A090739-004	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 4 · 153 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
2026-09-14 22:38:34	2026-08	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090739-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090739-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090739-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090739-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-004	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-257-04	EA - Each	68001-257	8b0351a4-6370-44fe-9040-a8764957f258	1	2014-07-02
68001-257-08	EA - Each	68001-257	be5dd70f-564e-4d9d-acde-d5f5974dc261	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	6

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Zydus Lifesciences Limited	f36b414e-ace4-4f04-a80f-75bb25db430d	2024-11-28		Exact identifier application applno (ANDA): 090739 application number: ANDA090739

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-257-04	68001025704	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-257-04)	2014-03-14	0000-00-00	No	No	Current
68001-257-08	68001025708	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-257-08)	2017-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	BluePoint Laboratories \| Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2021-07-14	HUMAN PRESCRIPTION DRUG LABEL	13