Doxepin Hydrochloride

Product NDC: 80425-0316
Requested package NDC: 80425-0316-3
11-digit product format: 804250316
Labeler code: 80425
Product ID: 80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA213063
Marketing category: ANDA
Marketing start: 2023-04-10
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	Approval date
A213063-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2020-07-01
A213063-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2020-07-01
A213063-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2020-07-01
A213063-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2020-07-01
A213063-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	2020-07-01

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 · 195 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	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`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
2025-08-23 18:47 UTC	2025-08	A213063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-005	AB	1	`d06236e962d9…`

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
f900bac4-02f2-6bf3-e053-6394a90a2161	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
80425-0316-1	Doxepin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
80425-0316-2	Doxepin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	2
80425-0316-3	Doxepin Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0316-1	EA - Each	80425-0316	28464baa-062f-4d04-b030-cd4f5b80a754	1	2023-06-06
80425-0316-2	EA - Each	80425-0316	7bca9d58-efc4-4209-8a21-2693fc3e32f3	1	2023-06-06
80425-0316-3	EA - Each	80425-0316	f2b33fc2-fff3-4425-b00a-1fb444945861	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0316	DOXEPIN HYDROCHLORIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250102_f900bac4-02f2-6bf3-e053-6394a90a2161.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin HCL	DOXEPIN HCL	Direct_Rx	dea965fe-6b54-bbf0-e053-2a95a90a1003	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	direct rx	b56cdaee-6187-c763-e053-2995a90acc3f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f900bac4-02f2-6bf3-e053-6394a90a2161	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (package): 80425-0316-3 ndc (product): 80425-0316 ndc11 (package): 80425031603
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063

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	f900bac4-02f2-6bf3-e053-6394a90a2161	2
1000070	doxepin 25 MG Oral Capsule	SCD	f900bac4-02f2-6bf3-e053-6394a90a2161	2
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	f900bac4-02f2-6bf3-e053-6394a90a2161	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0316-3	80425031603	90 CAPSULE in 1 BOTTLE (80425-0316-3)	90 capsule	2023-04-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin HCL Capsule	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2