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 4 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf900bac4-02f2-6bf3-e053-6394a90a21612024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213063
ndc (package): 80425-0316-1
ndc (package): 80425-0316-3
ndc (package): 80425-0316-2
ndc (product): 80425-0316
ndc11 (package): 80425031601
rxcui: 1000070
spl id: 2a9bf621-afbf-7627-e063-6294a90a77a9
spl set id: f900bac4-02f2-6bf3-e053-6394a90a2161
unii: 3U9A0FE9N5
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEGolden State Medical Supply, Inc.00ef7d0b-4bb9-cd5b-e063-6294a90abc352024-12-24Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack13da67ec-370c-4647-8440-80fd55f1398e2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HCLDOXEPIN HCLDirect_rx249c8a57-fbec-47d5-e063-6394a90a66962024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackeb6954cf-e96b-4e54-961d-6b094384bac92024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HCLDOXEPIN HCLDirect_rx21c64f9f-cee2-60b0-e063-6294a90ae97e2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214b6c28-7418-5ebd-e063-6394a90ae8332024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackefcae0f7-3491-470f-beea-1aff221782432024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions55a20aa1-fc9e-487d-9f8d-c4abf77ae2d22024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213063
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1cec730e-3218-ddf6-e063-6294a90a916e2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEEpic Pharma, LLC5f0f6fee-2497-4915-b58b-bf369efcfd792024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions890248d7-73b1-4ed3-b252-85775defdf342024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9ee26b24-7121-3107-e053-2995a90ac61c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackec948b3d-4853-41bb-9f01-faf28fe369e52024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack6e22050f-95ee-410a-b770-0c32fb8b321b2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepacka4c804e3-4706-48d8-b928-b22c2dcaeed82024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5
Doxepin HCLDOXEPIN HCLDirect_Rx0ead9074-3478-7c3d-e063-6394a90a9d272024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
unii: 3U9A0FE9N5
DoxepinDOXEPINArchis Pharma LLCe3eac8e4-224e-4b7b-81d3-071301f914fa2024-01-04Warnings, Adverse reactionsExact identifier
unii: 3U9A0FE9N5

Reported adverse events (FAERS/openFDA)#

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