doxepin hydrochloride

Product NDC: 51407-728
Requested package NDC: 51407-728-30
11-digit product format: 514070728
Labeler code: 51407
Product ID: 51407-728_57efdac6-7c96-5ff1-e063-6294a90adb10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxepin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA219058
Marketing category: ANDA
Marketing start: 2025-08-06
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
A219058-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2025-08-06
A219058-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB		2025-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219058-001	AB
A219058-002	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	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219058-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2025-08-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219058-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2025-08-06	`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	A219058-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219058-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219058-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219058-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219058-002	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 hydrochloride
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 · 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
57efdc34-d619-e413-e063-6394a90a0e04	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 hydrochloride	DOXEPIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	57efdc34-d619-e413-e063-6394a90a0e04	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219058 application number: ANDA219058 ndc (package): 51407-728-30 ndc (product): 51407-728 ndc11 (package): 51407072830
doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	554ab06f-6420-42b3-89d1-d97554c237d8	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219058 application number: ANDA219058

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
51407-728-30	51407072830	30 TABLET in 1 BOTTLE (51407-728-30)	30 tablet	2026-04-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxepin hydrochloride	Golden State Medical Supply, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	1