Doxepin Hydrochloride

Product NDC: 60429-968
11-digit product format: 604290968
Labeler code: 60429
Product ID: 60429-968_e093cf70-8086-7c50-e053-2995a90a1bb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA070791
Marketing category: ANDA
Marketing start: 1986-05-13
Marketing end: 0000-00-00
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 50 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60429-968		D	Discontinued by firm	2026-08-17
excluded package	package	60429-968	60429-968-01	D	Discontinued by firm	2026-08-17
excluded package	package	60429-968	60429-968-10	D	Discontinued by firm	2026-08-17

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	RLD / RS	Approval date
A070791-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13
A070791-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070791-001	AB
A070791-002	AB
A070791-003	AB
A070791-004	AB
A070791-005	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 · 210 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	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A070791-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070791-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070791-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070791-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-005	AB	1	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-968-01	EA - Each	60429-968	64b2fd5b-99c3-4ab3-939d-d1e25a68085e	1	2018-03-08
60429-968-10	EA - Each	60429-968	64fb565f-17a5-4826-bd2e-6b31e167612a	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-968	DOXEPIN HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	6	Legacy NDC	20241212_3e7b0562-15e0-4294-a826-01edc17a3ac0.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	c577af7c-2405-4454-a169-5b6a4fa0c7bf	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Safecor Health, LLC	a2297f75-c498-419b-aa29-057271313a7f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ede17e6-19e9-455c-ad16-8029a590735c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d2a91b99-513d-4894-ad6d-02d2028a2290	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Institutional Inc.	137a953b-3c48-405f-86a6-ff778cb7f5f2	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	10d9eba6-30d1-448a-8d92-a1a02df03303	2017-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791

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
60429-968-01	60429096801	100 CAPSULE in 1 BOTTLE, PLASTIC (60429-968-01)	100 capsule	2018-02-05	0000-00-00	No	No	Current
60429-968-10	60429096810	1000 CAPSULE in 1 BOTTLE, PLASTIC (60429-968-10)	1000 capsule	2018-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg*	Golden State Medical Supply, Inc.	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	6