DOXEPIN

Product NDC: 72603-919
Requested package NDC: 72603-919-01
11-digit product format: 726030919
Labeler code: 72603
Product ID: 72603-919_77782f36-d120-4c3d-bebd-c8b0f4749d98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXEPIN
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA216041
Marketing category: ANDA
Marketing start: 2026-08-01
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 3 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
A216041-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2024-07-25
A216041-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB		2024-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216041-001	AB
A216041-002	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.

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	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2024-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2024-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216041-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2024-07-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216041-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2024-07-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216041-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216041-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216041-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216041-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216041-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216041-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216041-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216041-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216041-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216041-002	AB	1	`6a471c1ec25d…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216041-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216041-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216041-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216041-002	AB	1	`a50c72e98297…`

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	3 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966787	Internal RxNorm lookup
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
77782f36-d120-4c3d-bebd-c8b0f4749d98	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXEPIN	DOXEPIN	NorthStar Rx LLC	77782f36-d120-4c3d-bebd-c8b0f4749d98	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216041 application number: ANDA216041 ndc (package): 72603-919-01 ndc (product): 72603-919 ndc11 (package): 72603091901
DOXEPIN	DOXEPIN	Aurobindo Pharma Limited	29b3bf98-2c57-4d87-b5eb-5232e46dc639	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216041 application number: ANDA216041

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3U9A0FE9N5	DOXEPIN HYDROCHLORIDE	1229-29-4	DOXEPIN HYDROCHLORIDE
5ASJ6HUZ7D	DOXEPIN	1668-19-5	DOXEPIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-919-01	72603091901	30 TABLET in 1 BOTTLE (72603-919-01)	30 tablet	2026-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXEPIN	NorthStar Rx LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-05-07	Human Prescription Drug Label	1