Duloxetine D/R

Product NDC: 72189-661
Requested package NDC: 72189-661-60
11-digit product format: 721890661
Labeler code: 72189
Product ID: 72189-661_4a67a77e-65b6-e70a-e063-6294a90a4375
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine D/R
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA208706
Marketing category: ANDA
Marketing start: 2026-02-09
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: 2027-12-31
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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	REMEDYREPACK INC.	ed164dbb-e713-42d1-a78e-31145578b9f8	2026-05-18	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 ndc (package): 72189-661-60 ndc (product): 72189-661 ndc11 (package): 72189066160
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

Additional Listing Data#

Finished product: Yes
Brand name base: Duloxetine D/R
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596930	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
4a66fde2-4cce-b92e-e063-6294a90a63ee	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	Strength	SPL version
72189-661-30	Duloxetine D/R	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		2
72189-661-60	Duloxetine D/R	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-661-30	EA - Each	72189-661	c3dfec4f-6755-483d-ad71-742bfa48f1d1	1	2026-03-17
72189-661-60	EA - Each	72189-661	461a95dd-5812-4420-953b-a53fb1de41d2	1	2026-03-17

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9044SC542W	DULOXETINE HYDROCHLORIDE	136434-34-9	DULOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	4a66fde2-4cce-b92e-e063-6294a90a63ee	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	4a66fde2-4cce-b92e-e063-6294a90a63ee	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	4a66fde2-4cce-b92e-e063-6294a90a63ee	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-661-60	72189066160	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-661-60)	2026-02-09	No	No	Current