Duloxetine

Product NDC: 85534-0050
11-digit product format: 855340050
Labeler code: 85534
Product ID: 85534-0050_5b0626a8-dcce-62ec-e063-6394a90abae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: HAWAII REPACK, INC
Application: ANDA090776
Marketing category: ANDA
Marketing start: 2013-12-17
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: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090776-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17
A090776-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17
A090776-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090776-001	AB
A090776-002	AB
A090776-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090776-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090776-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-17	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A090776-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090776-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090776-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090776-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090776-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090776-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090776-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090776-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090776-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090776-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090776-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090776-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090776-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090776-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090776-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090776-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090776-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090776-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090776-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090776-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090776-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090776-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090776-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090776-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090776-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090776-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090776-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090776-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090776-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090776-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090776-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090776-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090776-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090776-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090776-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090776-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090776-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090776-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090776-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090776-003	AB	1	`3a93d1ddd44b…`

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: 2027-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
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
b32a39d8-5f1a-4e44-bc46-b65925bde753	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	HAWAII REPACK, INC	b32a39d8-5f1a-4e44-bc46-b65925bde753	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776 ndc (product): 85534-0050
Duloxetine	DULOXETINE	Actavis Pharma, Inc.	9dab9154-b86f-40dc-a4d1-18e6534dbc78	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Bryant Ranch Prepack	ff118c08-2e64-4416-a996-fd9de45d018a	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Preferred Phamaceuticals Inc.	c5aac428-d929-4688-a9d5-4e9314aa62cc	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	NuCare Pharmaceuticals,Inc.	2d7c2a64-2ce0-f222-e063-6294a90a9056	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx of Tennessee, LLC	b33cbab8-1962-cb66-e053-2a95a90a4ae7	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Proficient Rx LP	3dec1805-9a95-462e-8784-303004d500b1	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Bryant Ranch Prepack	4673ccdd-c86c-4ddc-b462-941897ecfd22	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Bryant Ranch Prepack	726b3c3e-8266-4a8a-a426-899cecd4f87e	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776
Duloxetine	DULOXETINE	Asclemed USA, Inc.	7c755ca3-0855-4b54-80a8-01b85f8e644a	2022-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090776 application number: ANDA090776

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85534-0050-0	85534005000	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (85534-0050-0)	2026-07-02	No	No	Current
85534-0050-1	85534005001	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (85534-0050-1)	2026-07-02	No	No	Current
85534-0050-2	85534005002	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (85534-0050-2)	2026-07-02	No	No	Current
85534-0050-3	85534005003	120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (85534-0050-3)	2026-07-02	No	No	Current