Duloxetine

Product NDC: 71335-0509
Requested package NDC: 71335-0509-3
11-digit product format: 713350509
Labeler code: 71335
Product ID: 71335-0509_f56840bd-a85a-489d-ae5a-cf6fe696f1a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DULOXETINE HYDROCHLORIDE
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203088
Marketing category: ANDA
Marketing start: 2014-06-11
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: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0509	71335-0509-3	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203088-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203088-001	AB
A203088-002	AB
A203088-003	AB
A203088-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203088-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203088-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203088-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Duloxetine
Brand name suffix: Delayed-Release
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
0c82422a-d493-4dda-8626-0d9baa25db8c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0509-1	Duloxetine Delayed-Release	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	30	104
71335-0509-2	Duloxetine Delayed-Release	28 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	28	104
71335-0509-3	Duloxetine Delayed-Release	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	60	104
71335-0509-4	Duloxetine Delayed-Release	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	90	104
71335-0509-5	Duloxetine Delayed-Release	180 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	180	104
71335-0509-6	Duloxetine Delayed-Release	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	120	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0509-4	EA - Each	71335-0509	267a134c-7ecc-40e4-9995-484ed80560bc	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0509	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 6 package rows	20240822_0c82422a-d493-4dda-8626-0d9baa25db8c.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	00628e5e-4c5b-2573-e063-6294a90a0e3b	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	b9f20917-9529-4c62-bafe-baae7f8d6c77	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	29eacc40-cbec-4cc9-8556-773346617e85	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine	DULOXETINE HYDROCHLORIDE	Quallent Pharmaceuticals Health, LLC	31362045-201f-45f3-99f2-a5e322a0c30b	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3bae1317-4cc8-4d86-b1b6-15edee733a6d	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2c233b3f-83de-40c4-9f1d-81f901f89459	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	f66f63c8-51db-4183-a452-78205cf3a263	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	276ca221-354c-484d-93d5-0698cb2cfd56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a23e79b3-7bd3-4b83-beb0-dc23d4830e9e	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a891f20f-83ff-4960-81ef-9e74d01a452e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c934cc41-b40b-4c5c-b019-a749eec52d88	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca36f94c-2215-436f-ada8-7319f4f3e054	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	caef6f50-1571-4ec7-8f8c-42b924d323ee	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df61b895-c358-827b-e053-2995a90a9b60	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	41876761-9d5b-4190-a200-6a822c54582e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	0c82422a-d493-4dda-8626-0d9baa25db8c	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088 ndc (package): 71335-0509-3 ndc (product): 71335-0509 ndc11 (package): 71335050903
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca376622-d32c-4e6e-8af4-8e24a8d20d83	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	A-S Medication Solutions	be33f3cb-6fd1-4377-816e-84bd49370e9e	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088

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
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	0c82422a-d493-4dda-8626-0d9baa25db8c	104
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	0c82422a-d493-4dda-8626-0d9baa25db8c	104
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	0c82422a-d493-4dda-8626-0d9baa25db8c	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0509-3	71335050903	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-3)	2021-02-24	0000-00-00	No	No	Current