FDA.reportPublic FDA data

NDC 80425-0316-01 - Doxepin Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0316
Requested NDC
80425-0316-01
Package NDCs from labels
80425-0316-1, 80425-0316-2, 80425-0316-3, 80425-0316-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxepin Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0316-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE302
80425-0316-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE602
80425-0316-3Doxepin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0316DOXEPIN HYDROCHLORIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f900bac4-02f2-6bf3-e053-6394a90a2161.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0316-1EA - Each80425-031628464baa-062f-4d04-b030-cd4f5b80a75412023-06-06
80425-0316-2EA - Each80425-03167bca9d58-efc4-4209-8a21-2693fc3e32f312023-06-06
80425-0316-3EA - Each80425-0316f2b33fc2-fff3-4425-b00a-1fb44494586112023-06-06

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 2 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SilenorDOXEPIN HYDROCHLORIDECurrax Pharmaceuticals LLC1bec1223-5239-4eb6-a9e8-62444106d2c02026-04-21Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d2a91b99-513d-4894-ad6d-02d2028a22902026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPINNorth Star Rx LLC12edd5c6-c863-b83a-e063-6294a90a2f362025-12-30Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCe6a4cb10-1928-4abe-8797-404c9ddc37dd2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCd5df4beb-8048-4b83-aa59-19876437001d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutionse0460c02-3dae-4b19-845c-2ffcfb587f6d2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEChartwell RX, LLC33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEAjanta Pharma USA Inc.1513c98c-e7ef-4009-b932-6757048bb86a2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8f7e9677-cc84-414b-8eb8-33993d285bb32025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DoxepinDOXEPINMarlex Pharmaceuticals, Inc.06e79a65-1455-804e-e063-6394a90a2f3d2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack09a70f17-f934-4b4b-9277-6351d906ab472025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack55f7d7b5-b747-49ac-9bf0-1510987b02912025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1533343b-f1ed-4c3a-bb36-23a748452b052025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack94ee3c14-0ccc-4329-b012-63679a699a672025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEFirst Nation Group, LLC3d4f84a4-07a1-4d0e-85f5-dcd43b236a422025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

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