Doxepin HCL

Product NDC: 72189-355
Requested package NDC: 72189-355-30
11-digit product format: 721890355
Labeler code: 72189
Product ID: 72189-355_2c4c85cc-c2b7-ac98-e063-6294a90a973c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxepin HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA213063
Marketing category: ANDA
Marketing start: 2022-05-10
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-355	72189-355-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-355	72189-355-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A213063-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2020-07-01
A213063-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2020-07-01
A213063-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2020-07-01
A213063-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2020-07-01
A213063-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	2020-07-01

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 5 · 185 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
2026-02-19 14:30 UTC	2026-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A213063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-005	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxepin HCL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	10 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
1000048	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
dea965fe-6b54-bbf0-e053-2a95a90a1003	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
72189-355-30	Doxepin HCL	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-355-30	EA - Each	72189-355	e060689d-057a-42ab-95ea-08f722ce17cd	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-355	DOXEPIN HCL CAPSULE [DIRECT_RX]	3	Current NDC, Legacy NDC, 1 package rows	20250123_dea965fe-6b54-bbf0-e053-2a95a90a1003.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin HCL	DOXEPIN HCL	Direct_Rx	dea965fe-6b54-bbf0-e053-2a95a90a1003	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (package): 72189-355-30 ndc (product): 72189-355 ndc11 (package): 72189035530
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	direct rx	b56cdaee-6187-c763-e053-2995a90acc3f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f900bac4-02f2-6bf3-e053-6394a90a2161	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063

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	dea965fe-6b54-bbf0-e053-2a95a90a1003	3
1000048	doxepin 10 MG Oral Capsule	SCD	dea965fe-6b54-bbf0-e053-2a95a90a1003	3
1000048	doxepin (as doxepin HCl) 10 MG Oral Capsule	SY	dea965fe-6b54-bbf0-e053-2a95a90a1003	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-355-30	72189035530	30 CAPSULE in 1 BOTTLE (72189-355-30)	30 capsule	2022-05-10	0000-00-00	No	No	Current