Duloxetine

Product NDC: 27241-099
11-digit product format: 272410099
Labeler code: 27241
Product ID: 27241-099_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: 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208706-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2017-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-03-11	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208706-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208706-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208706-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208706-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208706-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208706-004	AB	1	`caaa826d4ba7…`
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…`

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
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 · 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
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
27241-099-03	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	18
27241-099-40	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	18
27241-099-90	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-099-03	EA - Each	27241-099	523df9f6-dfdf-4495-bbd4-270114ea392d	1	2017-09-11
27241-099-90	EA - Each	27241-099	fe22229d-a2d7-46e5-80f2-2b9dd47b2119	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-099	DULOXETINE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]	16	Current NDC, Legacy NDC, 3 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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Quallent Pharmaceuticals Health LLC	b3b26383-9924-40f9-b4bb-43e30b70493e	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Ajanta Pharma USA Inc.	2dde979d-b6f8-41d1-96fb-325c75ea3a74	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706 ndc (product): 27241-099
Duloxetine	DULOXETINE	BluePoint Laboratories	1409fc2b-7252-472f-b719-e56141b36da2	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Preferred Pharmaceuticals, Inc.	7a7c67be-6800-4ec3-9072-1e0e390a854b	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Asclemed USA, Inc.	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Coupler LLC	2d942e38-90d4-de39-e063-6294a90a9822	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	NuCare Pharmaceuticals, Inc.	2b61c261-d7f2-4f9d-e063-6294a90acc24	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	c4fa1d3b-f136-e14f-e053-2a95a90a6cfb	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine DR	DULOXETINE	Advanced Rx Pharmacy of Tennessee, LLC	b70035d4-5a3f-c5b5-e053-2995a90acac1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine DR	DULOXETINE	Advanced Rx Pharmacy of Tennessee, LLC	f8c0bc80-b34e-daa8-e053-6394a90a05c2	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Bryant Ranch Prepack	b19ba26f-4711-443e-83cf-5af7bb43a0a0	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Bryant Ranch Prepack	3fbdcc34-6166-4843-839c-33fed718ffb2	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	A-S Medication Solutions	6b1cac95-83e3-4fad-8d60-7a1a9e675eb2	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	A-S Medication Solutions	b6040e79-0bbd-41a3-ba86-2a360a41864c	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	A-S Medication Solutions	07a7dd8d-cbf8-4281-8583-d2d98711ed6c	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Proficient Rx LP	5410084d-a7db-4da1-a45d-24b91ef50404	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Proficient Rx LP	e36a6919-568a-4d4a-9920-7a7fe4f3441c	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
Duloxetine	DULOXETINE	Proficient Rx LP	39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb7	2022-06-01	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
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	db85a82d-84f1-41c8-964b-ac94ae4d8e7b	20
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	db85a82d-84f1-41c8-964b-ac94ae4d8e7b	20
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	db85a82d-84f1-41c8-964b-ac94ae4d8e7b	20
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	ba4adb77-45be-4310-a877-766692f22e5e	19
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	ba4adb77-45be-4310-a877-766692f22e5e	19
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	ba4adb77-45be-4310-a877-766692f22e5e	19
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
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	ac903bda-76af-4aba-9c8a-ebf7066e05ee	15
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	ac903bda-76af-4aba-9c8a-ebf7066e05ee	15
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	ac903bda-76af-4aba-9c8a-ebf7066e05ee	15
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	b19ba26f-4711-443e-83cf-5af7bb43a0a0	12
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	b19ba26f-4711-443e-83cf-5af7bb43a0a0	12
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	b19ba26f-4711-443e-83cf-5af7bb43a0a0	12
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	b70035d4-5a3f-c5b5-e053-2995a90acac1	8
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	b70035d4-5a3f-c5b5-e053-2995a90acac1	8
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	b70035d4-5a3f-c5b5-e053-2995a90acac1	8
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	556d7dd0-0e3d-4f70-9786-e546a43ef539	8
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	fa5657a8-c6d9-474a-9d1a-b75b41b4327f	7
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	fa5657a8-c6d9-474a-9d1a-b75b41b4327f	7
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	fa5657a8-c6d9-474a-9d1a-b75b41b4327f	7
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	7a7c67be-6800-4ec3-9072-1e0e390a854b	6
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	7a7c67be-6800-4ec3-9072-1e0e390a854b	6
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	7a7c67be-6800-4ec3-9072-1e0e390a854b	6
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
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	c194a7b0-1e7e-a32b-e053-2995a90a7dbd	4
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	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
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	c194a7b0-1e7e-a32b-e053-2995a90a7dbd	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	c194a7b0-1e7e-a32b-e053-2995a90a7dbd	4
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	f61bd9f3-cd3d-4c76-a110-0f1dcba610af	4
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	2425f770-a264-4aec-9439-7c2dbd2da548	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	07a7dd8d-cbf8-4281-8583-d2d98711ed6c	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	2425f770-a264-4aec-9439-7c2dbd2da548	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	9221f3e5-17b8-ea74-e053-2a95a90ad1a8	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	075fc7c9-7b4b-b9c3-e063-6394a90a926e	3
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	2425f770-a264-4aec-9439-7c2dbd2da548	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	075fc7c9-7b4b-b9c3-e063-6394a90a926e	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	9221f3e5-17b8-ea74-e053-2a95a90ad1a8	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	07a7dd8d-cbf8-4281-8583-d2d98711ed6c	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	2425f770-a264-4aec-9439-7c2dbd2da548	3
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	2425f770-a264-4aec-9439-7c2dbd2da548	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	07a7dd8d-cbf8-4281-8583-d2d98711ed6c	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	2425f770-a264-4aec-9439-7c2dbd2da548	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	075fc7c9-7b4b-b9c3-e063-6394a90a926e	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	9221f3e5-17b8-ea74-e053-2a95a90ad1a8	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	e36a6919-568a-4d4a-9920-7a7fe4f3441c	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	c482d64a-73dd-4af2-9b3c-efff47e7395c	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	e36a6919-568a-4d4a-9920-7a7fe4f3441c	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	c482d64a-73dd-4af2-9b3c-efff47e7395c	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	e36a6919-568a-4d4a-9920-7a7fe4f3441c	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	c482d64a-73dd-4af2-9b3c-efff47e7395c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-099-03	27241009903	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-03)	2017-03-16	0000-00-00	No	No	Current
27241-099-40	27241009940	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-40)	2021-10-18	0000-00-00	No	No	Current
27241-099-90	27241009990	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-099-90)	2017-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	REMEDYREPACK INC.	2026-10-07	HUMAN PRESCRIPTION DRUG LABEL	17
Duloxetine	HAWAII REPACK, INC.	2026-09-09	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Northwind Health Company, LLC	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	5
Duloxetine	St. Mary's Medical Park Pharmacy	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine	NuCare Pharmaceuticals,Inc.	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	3
Duloxetine	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	19
Duloxetine	PD-Rx Pharmaceuticals, Inc.	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	20
Duloxetine	A-S Medication Solutions	2025-12-31	Human Prescription Drug Label	7
Duloxetine	Aphena Pharma Solutions - Tennessee, LLC	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan \| Ajanta Pharma Ltd., Dahej	2025-08-29	Human Prescription Drug Label	18
Duloxetine	Preferred Pharmaceuticals, Inc.	2025-04-04	HUMAN PRESCRIPTION DRUG LABEL	6
Duloxetine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8
Duloxetine	Quality Care Products LLC	2024-12-18	Human Prescription Drug Label	9