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 5 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack2cacce3a-4986-44a8-b4aa-6edb076d87bf2023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack0cbf87df-c447-4225-81f5-92c4bc3ef81d2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP7cfbb3d0-f19f-4977-ad0f-77676a8c6f832023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLCdd8d5edd-7b08-4061-86e6-c4179da89c0d2023-08-17Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPINDOXEPINAurobindo Pharma Limited29b3bf98-2c57-4d87-b5eb-5232e46dc6392023-07-13Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack41046d94-1443-4bbd-96d0-8463604ae4592023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DoxepinDOXEPINActavis Pharma, Inc.c42333f8-1add-4f33-9458-6fe4436874a12023-06-01Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS14002bad-2577-436d-91ca-ec1b80ab0c972023-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Limited842b595b-dc54-4898-a178-1d2241cc065f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPacb696a8-a74c-4c5d-9ce3-88f67558c2f22022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP6ce7fde2-2d47-4238-9beb-555d352f46572022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
doxepin hydrochlorideDOXEPIN HYDROCHLORIDECurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5b4dba99-6b66-4091-94f1-bf5f021c688a2022-01-20Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEFlorida Pharmaceutical Products, LLCb787a283-f882-e1f0-e053-2a95a90a89752021-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
doxepin hydrochlorideDOXEPIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4a4eab1c-8e19-48f5-9216-09ab83eaa5f82021-06-01Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAppco Pharma LLCabf4c515-8888-4733-80a0-fd4e1cdb84a22021-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEContract Pharmacal Corp.abbf7078-a012-4e1a-e053-2995a90a792d2020-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC10d9eba6-30d1-448a-8d92-a1a02df033032017-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
PRUDOXINDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.ca53346b-8ab3-4722-98f6-cf272706d3fa2017-06-29Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
ZonalonDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.5f302247-525e-4acc-852b-00eb1d79af4b2017-06-14Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

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