doxepin hydrochloride

Product NDC: 44183-103
11-digit product format: 441830103
Labeler code: 44183
Product ID: 44183-103_db184464-82a3-4710-a6aa-6a1c437a7bfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
Application: NDA022036
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-08-01
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 3 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 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
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	44183-103		I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	44183-103	44183-103-30	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022036-001	SILENOR	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17
N022036-002	SILENOR	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022036-001	AB
N022036-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022036-001	10238620	2027-05-18	U-620		2019-04-08
N022036-001	10653662	2027-05-18	U-620		2020-06-15
N022036-001	12083090	2027-05-18	U-620		2024-10-10
N022036-001	9486437	2027-05-18	U-620		2016-12-02
N022036-001	9861607	2027-05-18	U-620		2018-01-24
N022036-001	10653660	2027-07-20	U-620		2020-06-15
N022036-001	11110074	2027-07-20	U-620		2021-09-22
N022036-001	9572814	2027-07-20	U-620		2017-03-21
N022036-001	7915307	2027-08-24	U-620
N022036-001	11234954	2028-01-18	U-620		2022-02-28
N022036-001	10548871	2028-04-11	U-620		2020-02-28
N022036-001	11096920	2028-04-11	U-620		2021-09-22
N022036-001	9907780	2028-04-11		Drug product	2018-03-26
N022036-001	9107898	2028-05-01	U-620		2015-09-09
N022036-001	9532971	2029-06-01		Drug product	2017-01-13
N022036-001	8513299	2030-09-07	U-620		2013-09-20
N022036-002	10238620	2027-05-18	U-620		2019-04-08
N022036-002	10653662	2027-05-18	U-620		2020-06-15
N022036-002	12083090	2027-05-18	U-620		2024-10-10
N022036-002	9486437	2027-05-18	U-620		2016-12-02
N022036-002	9861607	2027-05-18	U-620		2018-01-24
N022036-002	10653660	2027-07-20	U-620		2020-06-15
N022036-002	11110074	2027-07-20	U-620		2021-09-22
N022036-002	9572814	2027-07-20	U-620		2017-03-21
N022036-002	7915307	2027-08-24	U-620
N022036-002	11234954	2028-01-18	U-620		2022-02-28
N022036-002	10548871	2028-04-11	U-620		2020-02-28
N022036-002	11096920	2028-04-11	U-620		2021-09-22
N022036-002	9907780	2028-04-11		Drug product	2018-03-26
N022036-002	9107898	2028-05-01	U-620		2015-09-09
N022036-002	9532971	2029-06-01		Drug product	2017-01-13
N022036-002	8513299	2030-09-07	U-620

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 3 · 82 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	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL		RLD	2010-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL		RLD, RS	2010-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	N022036-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022036-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022036-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022036-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022036-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022036-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022036-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022036-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022036-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022036-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022036-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022036-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022036-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022036-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022036-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022036-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022036-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,184 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022036-001	10238620	2027-05-18	U-620		2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10653662	2027-05-18	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	12083090	2027-05-18	U-620		2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9486437	2027-05-18	U-620		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9861607	2027-05-18	U-620		2018-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10653660	2027-07-20	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11110074	2027-07-20	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9572814	2027-07-20	U-620		2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	7915307	2027-08-24	U-620			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11234954	2028-01-18	U-620		2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10548871	2028-04-11	U-620		2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11096920	2028-04-11	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9907780	2028-04-11		Drug product	2018-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9107898	2028-05-01	U-620		2015-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9532971	2029-06-01		Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	8513299	2030-09-07	U-620		2013-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10238620	2027-05-18	U-620		2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10653662	2027-05-18	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	12083090	2027-05-18	U-620		2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9486437	2027-05-18	U-620		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9861607	2027-05-18	U-620		2018-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10653660	2027-07-20	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11110074	2027-07-20	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9572814	2027-07-20	U-620		2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	7915307	2027-08-24	U-620			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11234954	2028-01-18	U-620		2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10548871	2028-04-11	U-620		2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11096920	2028-04-11	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9907780	2028-04-11		Drug product	2018-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9107898	2028-05-01	U-620		2015-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9532971	2029-06-01		Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	8513299	2030-09-07	U-620			`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10238620	2027-05-18	U-620		2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10653662	2027-05-18	U-620		2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	12083090	2027-05-18	U-620		2024-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9486437	2027-05-18	U-620		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9861607	2027-05-18	U-620		2018-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10653660	2027-07-20	U-620		2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	11110074	2027-07-20	U-620		2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9572814	2027-07-20	U-620		2017-03-21	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: doxepin hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3U9A0FE9N5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966787	Internal RxNorm lookup
966793	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
5b4dba99-6b66-4091-94f1-bf5f021c688a	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2025-11-12	These highlights do not include all the information needed to use Doxepin HCl Tablets safely and effectively. See full prescribing information for Doxepin HCl Tablets. Doxepin HCl Tablets for oral use Initial U.S. Approval: 1969
2025-11-12	These highlights do not include all the information needed to use Doxepin HCl Tablets safely and effectively. See full prescribing information for Doxepin HCl Tablets. Doxepin HCl Tablets for oral use Initial U.S. Approval: 1969
2025-07-29	These highlights do not include all the information needed to use Doxepin HCl Tablets safely and effectively. See full prescribing information for Doxepin HCl Tablets. Doxepin HCl Tablets for oral use Initial U.S. Approval: 1969
2025-07-29	These highlights do not include all the information needed to use Doxepin HCl Tablets safely and effectively. See full prescribing information for Doxepin HCl Tablets. Doxepin HCl Tablets for oral use Initial U.S. Approval: 1969

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44183-103-30	doxepin hydrochloride	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44183-103-30	EA - Each	44183-103	9255abf1-27dc-49b7-9516-9d98e650769a	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44183-103	DOXEPIN HYDROCHLORIDE TABLET [CURRAX PHARMACEUTICALS LLC DBA CYPRESS, HAWTHORN, MACOVEN]	3	Current NDC, Legacy NDC, 1 package rows	20220121_5b4dba99-6b66-4091-94f1-bf5f021c688a.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
Silenor	DOXEPIN HYDROCHLORIDE	Currax Pharmaceuticals LLC	1bec1223-5239-4eb6-a9e8-62444106d2c0	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022036 application number: NDA022036
doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	5b4dba99-6b66-4091-94f1-bf5f021c688a	2022-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022036 application number: NDA022036 ndc (product): 44183-103

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
966787	doxepin 3 MG Oral Tablet	PSN	5b4dba99-6b66-4091-94f1-bf5f021c688a	4
966793	doxepin 6 MG Oral Tablet	PSN	5b4dba99-6b66-4091-94f1-bf5f021c688a	4
966787	doxepin 3 MG Oral Tablet	SCD	5b4dba99-6b66-4091-94f1-bf5f021c688a	4
966793	doxepin 6 MG Oral Tablet	SCD	5b4dba99-6b66-4091-94f1-bf5f021c688a	4
966787	doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral Tablet	SY	5b4dba99-6b66-4091-94f1-bf5f021c688a	4
966793	doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral Tablet	SY	5b4dba99-6b66-4091-94f1-bf5f021c688a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44183-103-30	44183010330	30 TABLET in 1 BOTTLE (44183-103-30)	30 tablet	2010-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven \| Patheon Pharmaceuticals, Inc \| Ropack Inc. \| Teva API India Private Ltd.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4