Doxepin

Product NDC: 71335-3177
Requested package NDC: 71335-3177-1
11-digit product format: 713353177
Labeler code: 71335
Product ID: 71335-3177_87264c52-4386-43d6-88cb-0275236ba97a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202510
Marketing category: ANDA
Marketing start: 2022-09-12
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 6 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202510-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2020-07-24
A202510-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB		2020-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202510-001	AB
A202510-002	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 2 · 80 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
2026-10-15 13:18:30	2026-09	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2020-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2020-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2020-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2020-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2020-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2020-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2020-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2020-07-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202510-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202510-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202510-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202510-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202510-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202510-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202510-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202510-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202510-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202510-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202510-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202510-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202510-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202510-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202510-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202510-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202510-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202510-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202510-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202510-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202510-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202510-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202510-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202510-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202510-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202510-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202510-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202510-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202510-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202510-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202510-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202510-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202510-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202510-002	AB	1	`8072bd15b7f6…`
2020-12-22 03:56 UTC	2020-12	A202510-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202510-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202510-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202510-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202510-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202510-002	AB	1	`6a51e52b5d6a…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	6 mg/1

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	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	2a9c2159-e89e-47e4-b91c-ac5560607a2d	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202510 application number: ANDA202510
Doxepin	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	207bb11e-6029-4506-92d2-2d8a776b9408	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202510 application number: ANDA202510
Doxepin	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	bc3b0401-df4a-46a2-a29b-3d70e72aa88b	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202510 application number: ANDA202510
Doxepin	DOXEPIN HYDROCHLORIDE	Strides Pharma Science Limited	399866d5-3fa6-46d0-9c62-492d5997bc4f	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202510 application number: ANDA202510

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	Sample	Exclude flag	Status
71335-3177-1	71335317701	100 TABLET in 1 BOTTLE (71335-3177-1)	100 tablet	2026-09-24	No	No	Current