FDA.reportPublic FDA data

doxepin HCl 25 MG Oral Capsule

RxCUI
1000070
RxNorm name
doxepin HCl 25 MG Oral Capsule
Display name
doxepin HCl 25 MG Oral Capsule
Full name
doxepin HCl 25 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC538643c0-b8d1-d71f-e063-6294a90a77342026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCe6a4cb10-1928-4abe-8797-404c9ddc37dd2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEChartwell RX, LLC33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEAjanta Pharma USA Inc.1513c98c-e7ef-4009-b932-6757048bb86a2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8f7e9677-cc84-414b-8eb8-33993d285bb32025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack55f7d7b5-b747-49ac-9bf0-1510987b02912025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1533343b-f1ed-4c3a-bb36-23a748452b052025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEFirst Nation Group, LLC3d4f84a4-07a1-4d0e-85f5-dcd43b236a422025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENorthStar RxLLC03cef3a6-a63d-4082-a491-451b24227d9d2025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.89ed6385-cf6a-458e-81ea-c7f3fead41c52025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAurobindo Pharma Limitedf3c242dd-426e-4c69-8f21-2645361d5f272025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDELifestar Pharma LLCfdaf3bd7-c456-40bd-8bc3-2b67eb1846c82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Institutional Inc.137a953b-3c48-405f-86a6-ff778cb7f5f22025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 45 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
55f7d7b5-b747-49ac-9bf0-1510987b0291doxepin HCl 25 MG Oral Capsule [PSN] · doxepin 25 MG Oral Capsule [SCD] · doxepin (as doxepin HCl) 25 MG Oral Capsule [SY]31HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DOXEPIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DOXEPIN HYDROCHLORIDE CAPSULES. DOXEPIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 196920251016
214bae5d-36e2-47ae-e063-6294a90a7ddddoxepin HCl 25 MG Oral Capsule [PSN] · doxepin 25 MG Oral Capsule [SCD] · doxepin (as doxepin HCl) 25 MG Oral Capsule [SY]31Doxepin 25mg Capsule20240904
7cfbb3d0-f19f-4977-ad0f-77676a8c6f83doxepin HCl 25 MG Oral Capsule [PSN] · doxepin 25 MG Oral Capsule [SCD] · doxepin (as doxepin HCl) 25 MG Oral Capsule [SY]31Doxepin Hydrochloride Capsules, USP20230901
2b1f0144-65d8-451f-8054-6be1675f102cdoxepin HCl 25 MG Oral Capsule [PSN] · doxepin 25 MG Oral Capsule [SCD] · doxepin (as doxepin HCl) 25 MG Oral Capsule [SY]31Doxepin Hydrochloride Capsules, USP20220622
abbf7078-a012-4e1a-e053-2995a90a792ddoxepin HCl 25 MG Oral Capsule [PSN] · doxepin 25 MG Oral Capsule [SCD] · doxepin (as doxepin HCl) 25 MG Oral Capsule [SY]31Doxepin Hydrochloride Capsules, USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg20200806