Cymbalta

Product NDC: 52959-892
11-digit product format: 529590892
Labeler code: 52959
Product ID: 52959-892_908e6b8e-0116-4024-bcb4-4f27938301a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine hydrochloride
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: NDA021427
Marketing category: NDA
Marketing start: 2010-01-15
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: 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	52959-892		I	Inactivated by FDA	2026-10-15
excluded package	package	52959-892	52959-892-30	I	Inactivated by FDA	2026-10-15
excluded package	package	52959-892	52959-892-60	I	Inactivated by FDA	2026-10-15

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	52959-892-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-892-60	`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	52959-892-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-892-60	`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	52959-892-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-892-60	`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	52959-892-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-892-60	`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	52959-892-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-892-60	`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	52959-892-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-892-60	`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	52959-892-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-892-60	`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	52959-892-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-892-60	`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	52959-892-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-892-60	`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	52959-892-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-892-60	`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	52959-892-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-892-60	`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	52959-892-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-892-60	`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	52959-892-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-892-60	`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	52959-892-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-892-60	`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	52959-892-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-892-60	`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	52959-892-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-892-60	`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	52959-892-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-892-60	`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	52959-892-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-892-60	`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	52959-892-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-892-60	`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	52959-892-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-892-60	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N021427-001	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03
N021427-002	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03
N021427-004	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	N021427-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021427-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021427-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021427-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021427-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021427-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021427-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021427-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021427-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021427-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021427-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021427-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021427-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021427-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021427-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021427-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021427-002	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021427-001	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-002	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-004	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021427-001	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-002	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-004	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021427-001	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-002	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-004	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021427-001	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-002	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-004	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-001	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-002	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-004	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021427-001	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021427-002	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021427-004	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021427-001	NPP	2023-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-002	NPP	2023-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-004	NPP	2023-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021427-001	NPP	2023-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-002	NPP	2023-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-004	NPP	2023-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021427-001	NPP	2023-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-002	NPP	2023-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-004	NPP	2023-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-001	NPP	2023-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-002	NPP	2023-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-004	NPP	2023-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021427-001	NPP	2023-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-002	NPP	2023-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-004	NPP	2023-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021427-001	NPP	2023-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-002	NPP	2023-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-004	NPP	2023-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021427-001	NPP	2023-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-002	NPP	2023-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-004	NPP	2023-04-20	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N021427-001	NPP	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021427-002	NPP	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021427-004	NPP	2023-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-001	NPP	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-002	NPP	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-004	NPP	2023-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-001	NPP	2023-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-002	NPP	2023-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-004	NPP	2023-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-001	NPP	2023-04-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-002	NPP	2023-04-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-004	NPP	2023-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021427-001	NPP	2023-04-20	`3f0d92c62455…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
52959-892-30	2020-01-31	C162847	48780-1	9d75b9cf-f15e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Cymbalta safely and effectively. See full prescribing information for Cymbalta. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 2004
52959-892-60	2020-01-31	C162847	48780-1	9d75b9cf-f15e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Cymbalta safely and effectively. See full prescribing information for Cymbalta. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 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
52959-892-30	Cymbalta	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		1
52959-892-60	Cymbalta	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-892-30	EA - Each	52959-892	5eb28e3a-3b91-47b1-9d32-8669cc762f94	1	2012-07-24
52959-892-60	EA - Each	52959-892	4fa5f52e-f04d-4735-b002-5330ee1294b1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Duloxetine hydrochloride	ACTIVE INGREDIENT	9044SC542W	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Duloxetine	ACTIVE MOIETY	O5TNM5N07U	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)	INACTIVE INGREDIENT	24P2YXD2PW	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
Triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-892	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20111212_059d730b-4294-47e1-8399-4cb8c468cee8.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
615186	Cymbalta 60 MG Delayed Release Oral Capsule	PSN	059d730b-4294-47e1-8399-4cb8c468cee8	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	059d730b-4294-47e1-8399-4cb8c468cee8	1
615186	duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta]	SBD	059d730b-4294-47e1-8399-4cb8c468cee8	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	059d730b-4294-47e1-8399-4cb8c468cee8	1
615186	Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	059d730b-4294-47e1-8399-4cb8c468cee8	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	059d730b-4294-47e1-8399-4cb8c468cee8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-892-30	52959089230	30 in 1 BOTTLE	Historical
52959-892-60	52959089260	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cymbalta	H.J. Harkins Company, Inc. \| Eli Lilly and Company \| Evonik Degussa Corporation \| Lilly del Caribe, Inc. (PR06) \| Lilly del Caribe, Inc. (PR01) \| Eli Lilly and Company (Indianapolis) \| Sharp - Conshohocken \| Sharp - Allentown	2011-10-18	HUMAN PRESCRIPTION DRUG LABEL	1