FDA.reportPublic FDA data

NDC 0591-5633 - 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
0591-5633
Package NDCs from labels
0591-5633-01
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxepin Hydrochloride Capsules USP Revised: August 2007 Rx onlyWatson Laboratories, Inc.2007-10-25HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5633-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5633DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]131 package rows20071109_AA69C63C-CED6-4676-A16B-554F1AF7D210.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxepin hydrochlorideACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
DoxepinACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
colloidal silicon dioxideINACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
D & C Yellow No. 10INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
FD & C Green No. 3INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
FD & C Yellow No. 6INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
gelatinINACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
pregelatinzed starchINACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
starch (corn)INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HCLDOXEPIN HCLDirect_Rxdea965fe-6b54-bbf0-e053-2a95a90a10032025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1000048
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEdirect rxb56cdaee-6187-c763-e053-2995a90acc3f2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf900bac4-02f2-6bf3-e053-6394a90a21612024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack13da67ec-370c-4647-8440-80fd55f1398e2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HCLDOXEPIN HCLDirect_rx249c8a57-fbec-47d5-e063-6394a90a66962024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackeb6954cf-e96b-4e54-961d-6b094384bac92024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HCLDOXEPIN HCLDirect_rx21c64f9f-cee2-60b0-e063-6294a90ae97e2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214b6c28-7418-5ebd-e063-6394a90ae8332024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackefcae0f7-3491-470f-beea-1aff221782432024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions55a20aa1-fc9e-487d-9f8d-c4abf77ae2d22024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1cec730e-3218-ddf6-e063-6294a90a916e2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEEpic Pharma, LLC5f0f6fee-2497-4915-b58b-bf369efcfd792024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEA-S Medication Solutions890248d7-73b1-4ed3-b252-85775defdf342024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9ee26b24-7121-3107-e053-2995a90ac61c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackec948b3d-4853-41bb-9f01-faf28fe369e52024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack6e22050f-95ee-410a-b770-0c32fb8b321b2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepacka4c804e3-4706-48d8-b928-b22c2dcaeed82024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000097

Reported adverse events (FAERS/openFDA)#

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