Doxepin Hydrochloride

Product NDC: 68788-7731
Requested package NDC: 68788-7731-9
11-digit product format: 687887731
Labeler code: 68788
Product ID: 68788-7731_7abc750e-d135-4c75-8d21-06b4b2a0afbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA211603
Marketing category: ANDA
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7731	68788-7731-9	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 · 12 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211603-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27
A211603-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27
A211603-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27
A211603-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27
A211603-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A211603-001	AB
A211603-002	AB
A211603-003	AB
A211603-004	AB
A211603-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A211603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211603-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211603-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211603-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211603-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211603-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211603-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211603-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211603-005	AB	1	`03ed91905a0d…`

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
68788-7731-3	EA - Each	68788-7731	57150da1-19fd-4612-ba1e-52ff170e4da8	1	2020-09-14
68788-7731-6	EA - Each	68788-7731	6a4ed621-f2a2-420e-8e4e-0a3fccd1ad56	1	2020-09-14
68788-7731-9	EA - Each	68788-7731	a884af37-775f-4786-9924-69f3da6253cb	1	2020-09-14

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1496dfc1-de50-471c-be87-1f1e2b70ab5a	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aurobindo Pharma Limited	f3c242dd-426e-4c69-8f21-2645361d5f27	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2bf7d838-6274-4d8a-91cb-b27e1e81d273	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9ee26b24-7121-3107-e053-2995a90ac61c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	6ce7fde2-2d47-4238-9beb-555d352f4657	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	e98f371e-f7fe-4c8f-9491-6eb4c53d43ad	2021-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211603 application number: ANDA211603

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3U9A0FE9N5	DOXEPIN HYDROCHLORIDE	1229-29-4	DOXEPIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7731-9	68788773109	90 CAPSULE in 1 BOTTLE (68788-7731-9)	90 capsule	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride Capsules USP Rx only	Preferred Pharmaceuticals, Inc.	2021-04-27	HUMAN PRESCRIPTION DRUG LABEL	2