DULOXETINE

Product NDC: 61919-636
11-digit product format: 619190636
Labeler code: 61919
Product ID: 61919-636_49107644-9ba4-31b9-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DULOXETINE
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA090745
Marketing category: ANDA
Marketing start: 2017-02-20
Marketing end: 0000-00-00
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 20 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: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-636		I	Inactivated by FDA	2026-08-11
excluded package	package	61919-636	61919-636-20	I	Inactivated by FDA	2026-08-11
excluded package	package	61919-636	61919-636-60	I	Inactivated by FDA	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 · 66 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	61919-636-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-636-20	`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	61919-636-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-636-20	`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	61919-636-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-636-20	`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	61919-636-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-636-20	`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	61919-636-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-636-20	`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	61919-636-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-636-20	`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	61919-636-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-636-20	`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	61919-636-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-636-20	`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	61919-636-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-636-20	`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	61919-636-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-636-20	`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	61919-636-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-636-20	`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	61919-636-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-636-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-636-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-636-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-636-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-636-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-636-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-636-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-636-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-636-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-636-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-636-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-636-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-636-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-636-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-636-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-636-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-636-20	`e2bbac7714bc…`	`27bdfed8d636…`

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	Approval date
A090745-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-003	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 · 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	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-003	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	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090745-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090745-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090745-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090745-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090745-001	AB	1	`87673890dc5c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88	Product name	9	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7dd29e28-6b69-499b-9257-12a3b46ca283	Product name	1	20191120
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-636-20	2020-01-31	C162847	48780-1	9d75b9cf-fd91-f424-e053-dadaa90a57ce	DULOXETINE
61919-636-60	2020-01-31	C162847	48780-1	9d75b9cf-fd91-f424-e053-dadaa90a57ce	DULOXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-636-20	DULOXETINE	20 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	20		2
61919-636-60	DULOXETINE	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-636-20	EA - Each	61919-636	d16c3ee6-629c-44cc-bb11-3a246f109c5b	1	2017-03-06
61919-636-60	EA - Each	61919-636	0cb9d7d6-fe31-42bf-85b4-fe759cf3a96b	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-636	DULOXETINE CAPSULE, DELAYED RELEASE [DIRECT RX]	2	Legacy NDC, 2 package rows	20170221_48fb3410-bb87-42ce-e054-00144ff88e88.zip

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	Sun Pharmaceutical Industries, Inc.	f16beb64-5878-486a-82ee-8e83e728f26c	2021-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090745 application number: ANDA090745

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	48fb3410-bb87-42ce-e054-00144ff88e88	2
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	48fb3410-bb87-42ce-e054-00144ff88e88	2
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	48fb3410-bb87-42ce-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-636-20	61919063620	20 in 1 BOTTLE	Historical
61919-636-60	61919063660	60 in 1 BOTTLE	Historical