Cymbalta

Product NDC: 43353-303
11-digit product format: 433530303
Labeler code: 43353
Product ID: 43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine hydrochloride
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021427
Marketing category: NDA
Marketing start: 2004-08-24
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: No
Listing certified through: 2019-12-31
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	43353-303		I	Inactivated by FDA		2026-08-11
excluded package	package	43353-303	43353-303-19	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 1 · 42 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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`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	43353-303-19	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-303-19	`9bebd1f3094a…`	`5416666fcb17…`

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	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 · 123 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021427-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021427-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021427-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021427-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021427-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021427-001	AB	1	`5d02ea3f76ae…`

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…`

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
43353-303-19	2020-01-31	C162847	48780-1	9d75b9d1-2aab-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 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
43353-303-19	Cymbalta	3060 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	3060		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-303-19	EA - Each	43353-303	39f8abd7-e07c-4115-9683-dc96aa056800	1	2015-06-09

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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Duloxetine	ACTIVE MOIETY	O5TNM5N07U	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)	INACTIVE INGREDIENT	24P2YXD2PW	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-303	CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20140429_88b2461b-4a44-4899-b63d-bcecc754266f.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
Cymbalta	DULOXETINE HYDROCHLORIDE	Eli Lilly and Company	2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021427 application number: NDA021427

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
596932	Cymbalta 30 MG Delayed Release Oral Capsule	PSN	88b2461b-4a44-4899-b63d-bcecc754266f	2
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	88b2461b-4a44-4899-b63d-bcecc754266f	2
596932	duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta]	SBD	88b2461b-4a44-4899-b63d-bcecc754266f	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	88b2461b-4a44-4899-b63d-bcecc754266f	2
596932	Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	88b2461b-4a44-4899-b63d-bcecc754266f	2
596932	Cymbalta 30 MG Delayed Release Oral Capsule	SY	88b2461b-4a44-4899-b63d-bcecc754266f	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	88b2461b-4a44-4899-b63d-bcecc754266f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-303-19	43353030319	3060 in 1 BOTTLE, PLASTIC	Historical