Duloxetine hydrochloride

Product NDC: 64725-1100
11-digit product format: 647251100
Labeler code: 64725
Product ID: 64725-1100_1d38892a-0a36-46eb-9f99-7b91b7337fd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetin hydrochloride
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA090774
Marketing category: ANDA
Marketing start: 2013-12-11
Marketing end: 0000-00-00
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	64725-1100		I	Inactivated by FDA		2026-08-17
excluded package	package	64725-1100	64725-1100-1	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-1100-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-1100-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-1100-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-1100-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-1100-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-1100-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-1100-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-1100-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-1100-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-1100-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64725-1100-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64725-1100-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-1100-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-1100-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-1100-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-1100-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-1100-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-1100-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-1100-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-1100-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-1100-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-1100-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A090774-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090774-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090774-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11

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 · 126 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
2026-08-18 06:07:40	2026-07	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090774-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090774-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090774-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090774-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090774-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090774-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090774-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090774-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090774-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	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	A090774-002	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	A090774-003	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	A090774-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090774-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090774-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090774-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090774-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090774-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090774-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090774-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090774-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090774-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090774-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090774-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090774-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090774-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090774-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090774-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090774-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090774-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090774-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090774-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090774-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090774-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090774-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090774-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090774-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090774-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090774-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090774-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090774-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090774-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090774-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090774-001	AB	1	`4b0b4de00fa7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88	Product name	9	20210727
7dd29e28-6b69-499b-9257-12a3b46ca283	Product name	1	20191120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-1100-1	2020-01-31	C162847	48780-1	9d75b9cf-e195-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use duloxetine delayed-release capsules, USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules, USP. DULOXETINE delayed-release capsules USP, for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-1100-1	Duloxetine hydrochloride	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-1100	DULOXETINE HYDROCHLORIDE (DULOXETIN HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20141110_2b6118ba-344e-4b41-89fa-c16d6e50927f.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	2b6118ba-344e-4b41-89fa-c16d6e50927f	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	2b6118ba-344e-4b41-89fa-c16d6e50927f	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	2b6118ba-344e-4b41-89fa-c16d6e50927f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-1100-1	64725110001	30 in 1 BOTTLE	Historical