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 3 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENorthStar RxLLC03cef3a6-a63d-4082-a491-451b24227d9d2025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
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
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAurobindo Pharma Limitedf3c242dd-426e-4c69-8f21-2645361d5f272025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
doxepin hydrochlorideDOXEPIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.554ab06f-6420-42b3-89d1-d97554c237d82025-08-06Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDELifestar Pharma LLCfdaf3bd7-c456-40bd-8bc3-2b67eb1846c82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HCLDOXEPIN HCLDirect_Rx3a870ceb-5a95-9351-e063-6294a90a30272025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Institutional Inc.137a953b-3c48-405f-86a6-ff778cb7f5f22025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Inc.4920401a-cde5-404b-82aa-c3c0e89110652025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepack207bb11e-6029-4506-92d2-2d8a776b94082025-05-02Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepackbc3b0401-df4a-46a2-a29b-3d70e72aa88b2025-05-01Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDERising Pharma Holdings, Inc.66c6af99-9909-4b18-a43b-898a1c4a34d72025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DoxepinDOXEPIN HYDROCHLORIDEStrides Pharma Science Limited399866d5-3fa6-46d0-9c62-492d5997bc4f2025-03-21Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack06e027bb-516d-4a1d-b5a0-a66c051eb3672025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HCLDOXEPIN HCLDirect_Rxdea965fe-6b54-bbf0-e053-2a95a90a10032025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA213063
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEdirect rxb56cdaee-6187-c763-e053-2995a90acc3f2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213063
rxcui: 1000070
unii: 3U9A0FE9N5
doxepinDOXEPINZydus Lifesciences Limited1461ede6-24f0-42a1-b801-0cf4ef4049852025-01-08Exact identifier
unii: 3U9A0FE9N5
doxepinDOXEPINViona Pharmaceuticals Inc3377541d-db46-4fd9-9a4b-faa5f6108e672025-01-08Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

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