DOXEPIN HYDROCHLORIDE

Product NDC: 50090-7184
11-digit product format: 500907184
Labeler code: 50090
Product ID: 50090-7184_7bd0f29d-ffc3-496b-9fd7-16345aa76356
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXEPIN HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA215076
Marketing category: ANDA
Marketing start: 2021-04-23
Substance: DOXEPIN HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A215076-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215076-001	AB
A215076-002	AB
A215076-003	AB
A215076-004	AB
A215076-005	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 5 · 170 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
2026-08-18 06:07:40	2026-07	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`

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
2026-08-18 06:07:40	2026-07	A215076-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215076-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215076-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: DOXEPIN HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXEPIN HYDROCHLORIDE	50 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
1000076	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
890248d7-73b1-4ed3-b252-85775defdf34	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
50090-7184-1	DOXEPIN HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7184-1	EA - Each	50090-7184	46753088-aad4-429f-ae92-c30511664fd7	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7184	DOXEPIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]	1	Current NDC, 1 package rows	20240626_890248d7-73b1-4ed3-b252-85775defdf34.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	09a70f17-f934-4b4b-9277-6351d906ab47	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	21dc77be-23af-4a1f-b189-dfee8ae2f894	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4920401a-cde5-404b-82aa-c3c0e8911065	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	06e027bb-516d-4a1d-b5a0-a66c051eb367	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	19c8ad61-4e4f-4c59-b196-34a4e470459f	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
Doxepin HCL	DOXEPIN HCL	Direct_rx	21c64f9f-cee2-60b0-e063-6294a90ae97e	2024-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	214bae5d-36e2-47ae-e063-6294a90a7ddd	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1cec730e-3218-ddf6-e063-6294a90a916e	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	890248d7-73b1-4ed3-b252-85775defdf34	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076 ndc (product): 50090-7184
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	842b595b-dc54-4898-a178-1d2241cc065f	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076

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
1000076	doxepin HCl 50 MG Oral Capsule	PSN	890248d7-73b1-4ed3-b252-85775defdf34	1
1000076	doxepin 50 MG Oral Capsule	SCD	890248d7-73b1-4ed3-b252-85775defdf34	1
1000076	doxepin (as doxepin HCl) 50 MG Oral Capsule	SY	890248d7-73b1-4ed3-b252-85775defdf34	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7184-1	50090718401	30 CAPSULE in 1 BOTTLE (50090-7184-1)	30 capsule	2024-06-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxepin Hydrochloride Capsules, USP	A-S Medication Solutions	2024-06-25	Human Prescription Drug Label	1