Doxepin Hydrochloride

Product NDC: 71335-2817
Requested package NDC: 71335-2817-1
11-digit product format: 713352817
Labeler code: 71335
Product ID: 71335-2817_76790e6b-5c03-4e4d-9b29-d54f29d8e9fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA215710
Marketing category: ANDA
Marketing start: 2022-02-10
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A215710-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215710-001	AB
A215710-002	AB
A215710-003	AB
A215710-004	AB
A215710-005	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 · 170 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	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 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	A215710-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215710-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215710-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215710-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215710-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000070	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
55f7d7b5-b747-49ac-9bf0-1510987b0291	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2817-1	Doxepin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	1
71335-2817-2	Doxepin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	1
71335-2817-3	Doxepin Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	1
71335-2817-4	Doxepin Hydrochloride	18 in 1 BOTTLE	CAPSULE	18	1
71335-2817-5	Doxepin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2817-1	EA - Each	71335-2817	e0a6ad03-b288-4b59-9709-cc7281f60e76	1	2026-04-20
71335-2817-2	EA - Each	71335-2817	8d999cf0-6cc1-4b54-afdb-5701ebcf69ce	1	2026-04-20
71335-2817-3	EA - Each	71335-2817	c6ffcff0-9972-4340-a5c2-b76329d25b38	1	2026-04-20
71335-2817-4	EA - Each	71335-2817	09aa24ba-a937-4c5d-a784-cfdcb63fd2b8	1	2026-04-20
71335-2817-5	EA - Each	71335-2817	e6751997-c412-48cc-9f6e-448f197fb7e1	1	2026-04-20

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	Bryant Ranch Prepack	55f7d7b5-b747-49ac-9bf0-1510987b0291	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710 ndc (package): 71335-2817-1 ndc (product): 71335-2817 ndc11 (package): 71335281701
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	First Nation Group, LLC	3d4f84a4-07a1-4d0e-85f5-dcd43b236a42	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NorthStar RxLLC	03cef3a6-a63d-4082-a491-451b24227d9d	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Lifestar Pharma LLC	fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin HCL	DOXEPIN HCL	Direct_rx	249c8a57-fbec-47d5-e063-6394a90a6696	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	214b6c28-7418-5ebd-e063-6394a90ae833	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710

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
1000070	doxepin HCl 25 MG Oral Capsule	PSN	55f7d7b5-b747-49ac-9bf0-1510987b0291	1
1000070	doxepin 25 MG Oral Capsule	SCD	55f7d7b5-b747-49ac-9bf0-1510987b0291	1
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	55f7d7b5-b747-49ac-9bf0-1510987b0291	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2817-1	71335281701	30 CAPSULE in 1 BOTTLE (71335-2817-1)	30 capsule	2025-10-16	No	No	Current