Doxepin hydrochloride

Product NDC: 70518-3490
11-digit product format: 705183490
Labeler code: 70518
Product ID: 70518-3490_ebf0e263-2d73-e424-e053-2995a90a6593
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212624
Marketing category: ANDA
Marketing start: 2022-08-22
Marketing end: 0000-00-00
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-3490		D	Discontinued by firm		2026-08-17
excluded package	package	70518-3490	70518-3490-0	D	Discontinued by firm		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 · 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70518-3490		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3490	70518-3490-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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
A212624-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212624-001	AB
A212624-002	AB
A212624-003	AB
A212624-004	AB
A212624-005	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 5 · 200 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
2026-08-18 06:07:40	2026-07	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212624-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-005	AB	1	`2680178bc6a6…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3490	DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	3	Legacy NDC	20240113_6b387dbb-f6a7-44c5-888d-f66205e287f4.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	46be666a-fb9f-42a5-a55c-ea15fd5538c9	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Coupler LLC	54616c93-2325-4719-e063-6394a90a3910	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Coupler LLC	538643c0-b8d1-d71f-e063-6294a90a7734	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Ajanta Pharma USA Inc.	1513c98c-e7ef-4009-b932-6757048bb86a	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin HCL	DOXEPIN HCL	Direct_Rx	0ead9074-3478-7c3d-e063-6394a90a9d27	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	2cacce3a-4986-44a8-b4aa-6edb076d87bf	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	0cbf87df-c447-4225-81f5-92c4bc3ef81d	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	7cfbb3d0-f19f-4977-ad0f-77676a8c6f83	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	41046d94-1443-4bbd-96d0-8463604ae459	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	acb696a8-a74c-4c5d-9ce3-88f67558c2f2	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624

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
70518-3490-0	70518349000	30 CAPSULE in 1 BLISTER PACK (70518-3490-0)	30 capsule	2022-08-22	0000-00-00	No	No	Current