Doxepin Hydrochloride

Product NDC: 0904-7054
11-digit product format: 009047054
Labeler code: 0904
Product ID: 0904-7054_b96f2236-46f3-47c4-a658-aa3d30f56b0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA207482
Marketing category: ANDA
Marketing start: 2017-06-28
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 50 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 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
A207482-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28
A207482-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28
A207482-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28
A207482-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28
A207482-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207482-001	AB
A207482-002	AB
A207482-003	AB
A207482-004	AB
A207482-005	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-06-28	`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	A207482-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207482-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207482-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207482-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207482-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207482-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207482-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207482-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207482-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207482-005	AB	1	`2680178bc6a6…`

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	50 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000048	Internal RxNorm lookup
1000058	Internal RxNorm lookup
1000070	Internal RxNorm lookup
1000076	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
df3b6be0-6a64-4174-b351-dab2061f290e	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	Strength	SPL version
0904-7054-61	Doxepin Hydrochloride	100 in 1 CARTON	CAPSULE	100		9
0904-7054-61	Doxepin Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7054-61	EA - Each	0904-7054	81f61d92-bb1c-438c-9442-161dd3e3faa4	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7054	DOXEPIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 2 package rows	20241222_df3b6be0-6a64-4174-b351-dab2061f290e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	78cf65ff-43f9-4f5e-95dd-864acc89c02a	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207482 application number: ANDA207482
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Redpharm Drug	37451a61-ccb1-57b3-e063-6294a90a2592	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207482 application number: ANDA207482
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Major Pharmaceuticals	df3b6be0-6a64-4174-b351-dab2061f290e	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207482 application number: ANDA207482 ndc (product): 0904-7054
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	3bc72772-22ae-4f29-97ff-4a552b4df6d0	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207482 application number: ANDA207482
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	20bfb8af-7933-4e5c-a2b5-010659d9125b	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207482 application number: ANDA207482

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
1000048	doxepin HCl 10 MG Oral Capsule	PSN	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000058	doxepin HCl 100 MG Oral Capsule	PSN	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000070	doxepin HCl 25 MG Oral Capsule	PSN	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000076	doxepin HCl 50 MG Oral Capsule	PSN	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000048	doxepin 10 MG Oral Capsule	SCD	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000058	doxepin 100 MG Oral Capsule	SCD	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000070	doxepin 25 MG Oral Capsule	SCD	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000076	doxepin 50 MG Oral Capsule	SCD	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000058	doxepin (as doxepin HCl) 100 MG Oral Capsule	SY	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000070	doxepin (as doxepin HCl) 25 MG Oral Capsule	SY	df3b6be0-6a64-4174-b351-dab2061f290e	9
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	df3b6be0-6a64-4174-b351-dab2061f290e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7054-61	00904705461	100 BLISTER PACK in 1 CARTON (0904-7054-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2017-06-28	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) Rx only	Major Pharmaceuticals	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	9