Duloxetine

Product NDC: 68001-595
11-digit product format: 680010595
Labeler code: 68001
Product ID: 68001-595_3cc7677d-d409-c32e-e063-6294a90a94f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA208706
Marketing category: ANDA
Marketing start: 2023-07-28
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 30 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
A208706-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06
A208706-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06
A208706-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06
A208706-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208706-001	AB
A208706-002	AB
A208706-003	AB
A208706-004	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 · 164 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	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A208706-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208706-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208706-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208706-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208706-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208706-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208706-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208706-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208706-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208706-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208706-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208706-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208706-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	30 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
596934	Internal RxNorm lookup
616402	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
1409fc2b-7252-472f-b719-e56141b36da2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68001-595-04	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	5
68001-595-05	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	5
68001-595-08	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-595-04	EA - Each	68001-595	c6a58d29-92a1-4ace-a416-2ddd8f6cc3bc	1	2023-09-05
68001-595-05	EA - Each	68001-595	625ec3e2-2ef5-4338-9213-ce5e29a970a3	1	2023-09-05
68001-595-08	EA - Each	68001-595	d071cbbd-2b26-45ef-bea2-8c0f34e6b462	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-595	DULOXETINE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	4	Current NDC, 3 package rows	20240403_1409fc2b-7252-472f-b719-e56141b36da2.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 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	REMEDYREPACK INC.	ed164dbb-e713-42d1-a78e-31145578b9f8	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	St. Mary's Medical Park Pharmacy	9221f3e5-17b8-ea74-e053-2a95a90ad1a8	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	REMEDYREPACK INC.	ac903bda-76af-4aba-9c8a-ebf7066e05ee	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	St. Mary's Medical Park Pharmacy	9221aea1-8de1-b94e-e053-2a95a90a1eae	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	HAWAII REPACK, INC.	79bfd6be-a1ff-4786-b4e2-abbd0a3e3932	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	REMEDYREPACK INC.	b149641a-03e6-4fee-91f3-7ba8e01196bd	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	St. Mary's Medical Park Pharmacy	39fa4247-e864-f653-e063-6394a90ac98d	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	22a2ad76-0841-46fe-85e1-101afd924939	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	e86eb765-ac9c-4ed9-bce8-819151559394	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	NuCare Pharmaceuticals, Inc.	4e42a04a-ab8e-3ec9-e063-6394a90a4565	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	NuCare Pharmaceuticals,Inc.	075fc7c9-7b4b-b9c3-e063-6394a90a926e	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine D/R	DULOXETINE D/R	Direct_Rx	4a66fde2-4cce-b92e-e063-6294a90a63ee	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Bryant Ranch Prepack	5fa0eda4-0886-415c-a30c-ae9729f16974	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	REMEDYREPACK INC.	9286ec0b-45ae-4a09-a0ad-556ec92aab63	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	REMEDYREPACK INC.	ba4adb77-45be-4310-a877-766692f22e5e	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	PD-Rx Pharmaceuticals, Inc.	db85a82d-84f1-41c8-964b-ac94ae4d8e7b	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Northwind Health Company, LLC	c194a7b0-1e7e-a32b-e053-2995a90a7dbd	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	A-S Medication Solutions	fa5657a8-c6d9-474a-9d1a-b75b41b4327f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	A-S Medication Solutions	7685a825-3c06-433d-ba98-4019c6ed2583	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Aphena Pharma Solutions - Tennessee, LLC	c482d64a-73dd-4af2-9b3c-efff47e7395c	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706

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
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	1409fc2b-7252-472f-b719-e56141b36da2	5
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	1409fc2b-7252-472f-b719-e56141b36da2	5
616402	DULoxetine 40 MG Delayed Release Oral Capsule	PSN	1409fc2b-7252-472f-b719-e56141b36da2	5
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	1409fc2b-7252-472f-b719-e56141b36da2	5
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	1409fc2b-7252-472f-b719-e56141b36da2	5
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	1409fc2b-7252-472f-b719-e56141b36da2	5
616402	duloxetine 40 MG Delayed Release Oral Capsule	SCD	1409fc2b-7252-472f-b719-e56141b36da2	5
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	1409fc2b-7252-472f-b719-e56141b36da2	5
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	1409fc2b-7252-472f-b719-e56141b36da2	5
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	1409fc2b-7252-472f-b719-e56141b36da2	5
616402	duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	1409fc2b-7252-472f-b719-e56141b36da2	5
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	1409fc2b-7252-472f-b719-e56141b36da2	5
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	2d942e38-90d4-de39-e063-6294a90a9822	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	2d942e38-90d4-de39-e063-6294a90a9822	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	2d942e38-90d4-de39-e063-6294a90a9822	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68001-595-04	68001059504	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-04)	2024-02-22	No	No	Current
68001-595-05	68001059505	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-05)	2023-11-10	No	No	Current
68001-595-08	68001059508	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-08)	2023-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	BluePoint Laboratories \| Ajanta Pharma Limited \| Ajanta Pharma Ltd., Dahej	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	5
Duloxetine	Coupler LLC \| Ajanta Pharma Limited	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	1