Duloxetine

Product NDC: 55700-628
11-digit product format: 557000628
Labeler code: 55700
Product ID: 55700-628_87922ff5-6e15-4594-ba30-48bc4cf574d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA208706
Marketing category: ANDA
Marketing start: 2018-05-18
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-628		D	Discontinued by firm	2026-10-05
excluded package	package	55700-628	55700-628-30	D	Discontinued by firm	2026-10-05
excluded package	package	55700-628	55700-628-60	D	Discontinued by firm	2026-10-05
excluded package	package	55700-628	55700-628-90	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-628	55700-628-90	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	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 · 172 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
2026-09-14 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…`
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…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	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…`
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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-628-30	EA - Each	55700-628	291321d7-007c-4cdd-9da3-f36f8d75be71	1	2018-06-11
55700-628-60	EA - Each	55700-628	fe6d17f6-e074-4f41-8b95-19f030e2a696	1	2018-06-11
55700-628-90	EA - Each	55700-628	c41ca269-1ca1-440c-84b7-99ce335a8c8e	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-628	DULOXETINE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC]	9	Legacy NDC	20241220_e4728363-a9ce-456b-ab5e-7e66b64f8787.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 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Aphena Pharma Solutions - Tennessee, LLC	4121bd3f-2d6d-3bdd-e063-6294a90a3088	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208706 application number: ANDA208706
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-628-30	55700062830	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30)	2018-05-18	0000-00-00	No	No	Current
55700-628-60	55700062860	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60)	2018-05-18	0000-00-00	No	No	Current
55700-628-90	55700062890	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-90)	2022-03-22	0000-00-00	No	No	Current