Duloxetine

Product NDC: 0228-2892
11-digit product format: 002282892
Labeler code: 0228
Product ID: 0228-2892_8b9c71de-82c9-44a5-b2d5-8c6b3141e4ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA090776
Marketing category: ANDA
Marketing start: 2013-12-17
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
unfinished product	product	0228-2892		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	0228-2892	0228-2892-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 · 28 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0228-2892-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0228-2892-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0228-2892-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0228-2892-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0228-2892-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0228-2892-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0228-2892-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0228-2892-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0228-2892-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0228-2892-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0228-2892-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0228-2892-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0228-2892-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0228-2892-00	`50b4072663b7…`	`eae3003ed65e…`

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	TE codes	Approval date
A090776-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17
A090776-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17
A090776-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090776-001	AB
A090776-002	AB
A090776-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 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	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090776-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090776-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090776-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090776-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090776-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090776-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Duloxetine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9044SC542W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
596934	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9dab9154-b86f-40dc-a4d1-18e6534dbc78	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0228-2892-03	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	30		28
0228-2892-96	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	1000		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2892-03	EA - Each	0228-2892	8f3d200d-36a7-44c7-ab62-63bb650cb5d3	1	2014-01-04
0228-2892-96	EA - Each	0228-2892	87c17b25-339b-4e7f-8602-833fbf590f8d	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2892	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]	26	Current NDC, Legacy NDC, 2 package rows	20240510_9dab9154-b86f-40dc-a4d1-18e6534dbc78.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	HAWAII REPACK, INC	b32a39d8-5f1a-4e44-bc46-b65925bde753	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Actavis Pharma, Inc.	9dab9154-b86f-40dc-a4d1-18e6534dbc78	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776 ndc (product): 0228-2892
Duloxetine	DULOXETINE	Bryant Ranch Prepack	ff118c08-2e64-4416-a996-fd9de45d018a	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Preferred Phamaceuticals Inc.	c5aac428-d929-4688-a9d5-4e9314aa62cc	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	NuCare Pharmaceuticals,Inc.	2d7c2a64-2ce0-f222-e063-6294a90a9056	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx of Tennessee, LLC	b33cbab8-1962-cb66-e053-2a95a90a4ae7	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Proficient Rx LP	3dec1805-9a95-462e-8784-303004d500b1	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Bryant Ranch Prepack	4673ccdd-c86c-4ddc-b462-941897ecfd22	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Bryant Ranch Prepack	726b3c3e-8266-4a8a-a426-899cecd4f87e	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Asclemed USA, Inc.	7c755ca3-0855-4b54-80a8-01b85f8e644a	2022-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776

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
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	726b3c3e-8266-4a8a-a426-899cecd4f87e	104
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	726b3c3e-8266-4a8a-a426-899cecd4f87e	104
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	726b3c3e-8266-4a8a-a426-899cecd4f87e	104
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	ff118c08-2e64-4416-a996-fd9de45d018a	102
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	ff118c08-2e64-4416-a996-fd9de45d018a	102
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	ff118c08-2e64-4416-a996-fd9de45d018a	102
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	4673ccdd-c86c-4ddc-b462-941897ecfd22	100
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	4673ccdd-c86c-4ddc-b462-941897ecfd22	100
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	4673ccdd-c86c-4ddc-b462-941897ecfd22	100
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	9dab9154-b86f-40dc-a4d1-18e6534dbc78	28
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	42c2fa9a-fe8f-46dd-93b3-3784a3c62d36	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	42c2fa9a-fe8f-46dd-93b3-3784a3c62d36	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	42c2fa9a-fe8f-46dd-93b3-3784a3c62d36	3
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	c5aac428-d929-4688-a9d5-4e9314aa62cc	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	c5aac428-d929-4688-a9d5-4e9314aa62cc	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	c5aac428-d929-4688-a9d5-4e9314aa62cc	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	c5aac428-d929-4688-a9d5-4e9314aa62cc	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	c5aac428-d929-4688-a9d5-4e9314aa62cc	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	c5aac428-d929-4688-a9d5-4e9314aa62cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2892-00	00228289200	10209 CAPSULE, DELAYED RELEASE PELLETS in 1 CONTAINER (0228-2892-00)	01-FEB-24				Current
0228-2892-03	00228289203	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-03)	2013-12-17	0000-00-00	No	No	Current
0228-2892-96	00228289296	1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96)	2014-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	HAWAII REPACK, INC	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	Actavis Pharma, Inc.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	28
Duloxetine	Bryant Ranch Prepack	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	102
Duloxetine	Preferred Phamaceuticals Inc.	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	Bryant Ranch Prepack	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	100
Duloxetine	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	104
Duloxetine	Unit Dose Services	2017-11-30	HUMAN PRESCRIPTION DRUG LABEL	3