Duloxetine Hydrochloride

Product NDC: 46708-129
11-digit product format: 467080129
Labeler code: 46708
Product ID: 46708-129_53df64fc-7fec-4c14-8fe3-c6a128be814a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA202949
Marketing category: ANDA
Marketing start: 2014-06-09
Marketing end: 0000-00-00
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	46708-129		I	Inactivated by FDA	2026-08-11
excluded package	package	46708-129	46708-129-10	I	Inactivated by FDA	2026-08-11
excluded package	package	46708-129	46708-129-30	I	Inactivated by FDA	2026-08-11
excluded package	package	46708-129	46708-129-90	I	Inactivated by FDA	2026-08-11
excluded package	package	46708-129	46708-129-91	I	Inactivated by FDA	2026-08-11

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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46708-129-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46708-129-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46708-129-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46708-129-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46708-129-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46708-129-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46708-129-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46708-129-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46708-129-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46708-129-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46708-129-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46708-129-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46708-129-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46708-129-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46708-129-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46708-129-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46708-129-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46708-129-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46708-129-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46708-129-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46708-129-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46708-129-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46708-129-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46708-129-91	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46708-129-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46708-129-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46708-129-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46708-129-91	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46708-129-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46708-129-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46708-129-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46708-129-91	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46708-129-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46708-129-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46708-129-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46708-129-91	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46708-129-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46708-129-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46708-129-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46708-129-91	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46708-129-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46708-129-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46708-129-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46708-129-91	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46708-129-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46708-129-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46708-129-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46708-129-91	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202949-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09
A202949-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09
A202949-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202949-001	AB
A202949-002	AB
A202949-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202949-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A202949-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202949-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202949-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202949-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202949-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202949-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202949-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202949-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202949-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202949-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202949-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202949-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202949-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202949-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202949-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202949-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202949-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202949-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202949-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202949-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88	Product name	9	20210727
7dd29e28-6b69-499b-9257-12a3b46ca283	Product name	1	20191120

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
46708-129-10	These highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-129-30	These highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-129-90	These highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004
46708-129-91	These highlights do not include all the information needed to use duloxetine delayed-release capsules safely and effectively. See full prescribing information for duloxetine delayed-release capsules. DULOXETINE delayed-release capsules for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-129-10	Duloxetine Hydrochloride30 mg	100 in 1 CARTON	CAPSULE, DELAYED RELEASE	100	1
46708-129-30	Duloxetine Hydrochloride30 mg	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	1
46708-129-90	Duloxetine Hydrochloride30 mg	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1
46708-129-91	Duloxetine Hydrochloride30 mg	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-129	DULOXETINE HYDROCHLORIDE 20 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 30 MG (DULOXETINE) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE 60 MG (DULOXETINE) CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1	Legacy NDC, 4 package rows	20140620_53df64fc-7fec-4c14-8fe3-c6a128be814a.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DULOXETINE HYDROCHLORIDE	DULOXETINE	Alembic Pharmaceuticals Inc.	39453971-766d-45bf-a0fd-4658d72bae72	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202949 application number: ANDA202949
DULOXETINE HYDROCHLORIDE	DULOXETINE	Alembic Pharmaceuticals Limited	05a744a5-64ef-42d7-a19c-568be5a272d4	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202949 application number: ANDA202949

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	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	53df64fc-7fec-4c14-8fe3-c6a128be814a	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	53df64fc-7fec-4c14-8fe3-c6a128be814a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
46708-129-10	46708012910	100 in 1 CARTON	Historical
46708-129-30	46708012930	30 in 1 BOTTLE	Historical
46708-129-90	46708012990	90 in 1 BOTTLE	Historical
46708-129-91	46708012991	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine Hydrochloride 20 mg	Alembic Pharmaceuticals Limited	2014-06-13	Human Prescription Drug Label	1