Duloxetine

Product NDC: 27241-097
11-digit product format: 272410097
Labeler code: 27241
Product ID: 27241-097_ae1a8c02-c1fc-474a-9411-cebecd99e339
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA208706
Marketing category: ANDA
Marketing start: 2017-03-16
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 20 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	20 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
2dde979d-b6f8-41d1-96fb-325c75ea3a74	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
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
27241-097-05	Duloxetine	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	18
27241-097-06	Duloxetine	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	18
27241-097-10	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	18
27241-097-90	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-097-06	EA - Each	27241-097	c2fd0673-0283-43e5-9dca-6bb49e02c629	1	2017-09-11
27241-097-10	EA - Each	27241-097	51a5a3f8-7ff5-407f-9b8d-fab8605b348e	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-097	DULOXETINE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]	16	Current NDC, Legacy NDC, 4 package rows	20230908_2dde979d-b6f8-41d1-96fb-325c75ea3a74.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	9286ec0b-45ae-4a09-a0ad-556ec92aab63	21
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	9286ec0b-45ae-4a09-a0ad-556ec92aab63	21
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	9286ec0b-45ae-4a09-a0ad-556ec92aab63	21
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
616402	DULoxetine 40 MG Delayed Release Oral Capsule	PSN	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
616402	duloxetine 40 MG Delayed Release Oral Capsule	SCD	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
616402	duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	2dde979d-b6f8-41d1-96fb-325c75ea3a74	18
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	5410084d-a7db-4da1-a45d-24b91ef50404	5
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	5410084d-a7db-4da1-a45d-24b91ef50404	5
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	5410084d-a7db-4da1-a45d-24b91ef50404	5
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	7685a825-3c06-433d-ba98-4019c6ed2583	4
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
616402	DULoxetine 40 MG Delayed Release Oral Capsule	PSN	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	7685a825-3c06-433d-ba98-4019c6ed2583	4
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
616402	duloxetine 40 MG Delayed Release Oral Capsule	SCD	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	7685a825-3c06-433d-ba98-4019c6ed2583	4
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
616402	duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	59d93257-237a-43ac-b1ab-0905246fb60e	2
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	f8c0bc80-b34e-daa8-e053-6394a90a05c2	2
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	f8c0bc80-b34e-daa8-e053-6394a90a05c2	2
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	59d93257-237a-43ac-b1ab-0905246fb60e	2
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	59d93257-237a-43ac-b1ab-0905246fb60e	2
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	f8c0bc80-b34e-daa8-e053-6394a90a05c2	2
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	5fa0eda4-0886-415c-a30c-ae9729f16974	1
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	4e42a04a-ab8e-3ec9-e063-6394a90a4565	1
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	39fa4247-e864-f653-e063-6394a90ac98d	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	5fa0eda4-0886-415c-a30c-ae9729f16974	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	4e42a04a-ab8e-3ec9-e063-6394a90a4565	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	39fa4247-e864-f653-e063-6394a90ac98d	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	5fa0eda4-0886-415c-a30c-ae9729f16974	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	4e42a04a-ab8e-3ec9-e063-6394a90a4565	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	39fa4247-e864-f653-e063-6394a90ac98d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-097-05	27241009705	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-05)	2021-10-18	0000-00-00	No	No	Current
27241-097-06	27241009706	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-06)	2017-03-16	0000-00-00	No	No	Current
27241-097-10	27241009710	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-10)	2017-03-16	0000-00-00	No	No	Current
27241-097-90	27241009790	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-097-90)	2021-10-18	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	St. Mary's Medical Park Pharmacy	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	3
Duloxetine	Preferred Pharmaceuticals Inc.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine - Northwestern Memorial HealthCare	Northwestern Memorial HealthCare	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	NuCare Pharmaceuticals, Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	Bryant Ranch Prepack	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	REMEDYREPACK INC.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	21
Duloxetine	A-S Medication Solutions	2025-12-10	Human Prescription Drug Label	4
Duloxetine	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan \| Ajanta Pharma Ltd., Dahej	2025-08-29	Human Prescription Drug Label	18
Duloxetine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine HCL DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Quality Care Products, LLC	2024-12-18	Human Prescription Drug Label	7
Duloxetine	RPK Pharmaceuticals, Inc.	2023-08-10	Human Prescription Drug Label	2
Duloxetine	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	5