Doxepin

Product NDC: 70518-4327
Requested package NDC: 70518-4327-0
11-digit product format: 705184327
Labeler code: 70518
Product ID: 70518-4327_5aac15e9-41c2-f6f1-e063-6394a90a47df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202510
Marketing category: ANDA
Marketing start: 2025-04-13
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 43.

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 · 78 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	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…`
2022-03-09 01:35 UTC	2022-03	A202510-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2020-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202510-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2020-07-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	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…`
2024-02-18 07:12 UTC	2024-02	A202510-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202510-002	AB	1	`1c564ffb4f44…`

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

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
966793	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
2a9c2159-e89e-47e4-b91c-ac5560607a2d	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
70518-4327-0	Doxepin	30 in 1 BOX	TABLET	30		1
70518-4327-1	Doxepin	1 in 1 POUCH	TABLET	1		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 ndc (package): 70518-4327-0 ndc (product): 70518-4327 ndc11 (package): 70518432700
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966793	doxepin 6 MG Oral Tablet	PSN	2a9c2159-e89e-47e4-b91c-ac5560607a2d	1
966793	doxepin 6 MG Oral Tablet	SCD	2a9c2159-e89e-47e4-b91c-ac5560607a2d	1
966793	doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral Tablet	SY	2a9c2159-e89e-47e4-b91c-ac5560607a2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4327-0	70518432700	30 POUCH in 1 BOX (70518-4327-0) / 1 TABLET in 1 POUCH (70518-4327-1)	30 pouch	2025-04-13	No	No	Current