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 4 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HCLDOXEPIN HCLDirect_Rx0ead9074-3478-7c3d-e063-6394a90a9d272024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack2cacce3a-4986-44a8-b4aa-6edb076d87bf2023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack0cbf87df-c447-4225-81f5-92c4bc3ef81d2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP7cfbb3d0-f19f-4977-ad0f-77676a8c6f832023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack41046d94-1443-4bbd-96d0-8463604ae4592023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS14002bad-2577-436d-91ca-ec1b80ab0c972023-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Limited842b595b-dc54-4898-a178-1d2241cc065f2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPacb696a8-a74c-4c5d-9ce3-88f67558c2f22022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP6ce7fde2-2d47-4238-9beb-555d352f46572022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEFlorida Pharmaceutical Products, LLCb787a283-f882-e1f0-e053-2a95a90a89752021-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAppco Pharma LLCabf4c515-8888-4733-80a0-fd4e1cdb84a22021-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEContract Pharmacal Corp.abbf7078-a012-4e1a-e053-2995a90a792d2020-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC10d9eba6-30d1-448a-8d92-a1a02df033032017-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000070
E07C6476-CCDB-83E4-4641-BD7AFEE03C56AA69C63C-CED6-4676-A16B-554F1AF7D2102007-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: E07C6476-CCDB-83E4-4641-BD7AFEE03C56
spl set id: AA69C63C-CED6-4676-A16B-554F1AF7D210

Reported adverse events (FAERS/openFDA)#

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