Doxepin Hydrochloride

Product NDC: 45865-968
11-digit product format: 458650968
Labeler code: 45865
Product ID: 45865-968_9af00e2c-7557-4bcf-e053-2995a90a96f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA071422
Marketing category: ANDA
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-968		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-968	45865-968-30	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-968-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-968-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-968-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-968-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-968-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-968-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-968-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-968-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-968-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A071422-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1987-11-09
A071422-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	1987-11-09
A071422-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	1987-11-09
A071422-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	1987-11-09
A071422-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	1987-11-09
A071422-006	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	1987-11-09

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 7 · 247 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
2026-08-18 06:07:40	2026-07	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			1987-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-005	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL			1987-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-006	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	1987-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-004	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL			1987-11-09	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 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	A071422-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071422-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071422-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071422-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071422-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071422-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071422-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071422-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071422-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071422-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071422-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071422-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071422-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071422-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071422-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071422-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071422-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071422-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071422-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071422-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071422-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071422-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071422-004	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6fcd62d-384f-5faa-05d7-c5d5903c6c43	Product name	4	20250515
3d5463a5-d368-9c2b-b40c-0f2b688e406e	Product name	9	20240805
750bc85a-c69c-4145-a865-3f1124677d16	Product name	3	20240321
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-968-30	2025-01-30	C162847	48780-1	2cef2736-aca7-d83d-e063-dadaa90ab31f	Doxepin Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-968-30	Doxepin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-968	DOXEPIN HYDROCHLORIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20191231_9aefefcd-d1c4-f666-e053-2a95a90a8e82.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000048	doxepin HCl 10 MG Oral Capsule	PSN	9aefefcd-d1c4-f666-e053-2a95a90a8e82	1
1000048	doxepin 10 MG Oral Capsule	SCD	9aefefcd-d1c4-f666-e053-2a95a90a8e82	1
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	9aefefcd-d1c4-f666-e053-2a95a90a8e82	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-968-30	45865096830	30 CAPSULE in 1 BOTTLE (45865-968-30)	30 capsule	2019-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride Capsules	medsource pharmaceuticals	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1