Duloxetine

Product NDC: 45865-813
11-digit product format: 458650813
Labeler code: 45865
Product ID: 45865-813_9ab40f3c-d695-e12a-e053-2995a90a2b3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA090723
Marketing category: ANDA
Marketing start: 2014-06-18
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: 2020-12-31
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	45865-813		I	Inactivated by FDA	2026-08-11
excluded package	package	45865-813	45865-813-30	I	Inactivated by FDA	2026-08-11
excluded package	package	45865-813	45865-813-60	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 1 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-813-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-813-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-813-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-813-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-813-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-813-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-813-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-813-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-813-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-813-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-813-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-813-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-813-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-813-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-813-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-813-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-813-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-813-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090723-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090723-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090723-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090723-003	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	A090723-001	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	A090723-002	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	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090723-003	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	A090723-001	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	A090723-002	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	A090723-003	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	A090723-001	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	A090723-002	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	A090723-003	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	A090723-001	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	A090723-002	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	A090723-003	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	A090723-001	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	A090723-002	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	A090723-003	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	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090723-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090723-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090723-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090723-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090723-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090723-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090723-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090723-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090723-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090723-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090723-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090723-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090723-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090723-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090723-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090723-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090723-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090723-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090723-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090723-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090723-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090723-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090723-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090723-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090723-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090723-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090723-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090723-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090723-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090723-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090723-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090723-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090723-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090723-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090723-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090723-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090723-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090723-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090723-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090723-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090723-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090723-003	AB	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A090723-001	AB	1	`1c564ffb4f44…`

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-813-30	2025-01-31	C162847	48780-1	f386c649-a4dc-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004
45865-813-60	2025-01-31	C162847	48780-1	f386c649-a4dc-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine . DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-813-30	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	30		2
45865-813-60	Duloxetine	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-813	DULOXETINE CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20191228_2084fc8f-b9f9-65e2-e054-00144ff8d46c.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 HYDROCHLORIDE	MARKSANS PHARMA LIMITED	3686cde5-f76d-4d16-aa5d-caceb8408f8c	2023-10-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090723 application number: ANDA090723

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
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	2084fc8f-b9f9-65e2-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-813-30	45865081330	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-30)	2015-09-22	0000-00-00	No	No	Current
45865-813-60	45865081360	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-813-60)	2015-09-22	0000-00-00	No	No	Current