FDA.reportPublic FDA data

NDC 66277-239 - Durela

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
66277-239
Package NDCs from labels
66277-239-30
Manufacturer
Galephar Pharmaceutical Research Inc.
Effective date
2024-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Durela - Galephar Pharmaceutical Research Inc.Galephar Pharmaceutical Research Inc.2024-12-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66277-239-30Durela30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66277-239DURELA (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]41 package rows20241208_d787c214-e8fe-1da1-e053-2a95a90a4288.zip

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 6 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93c9c960-afbf-6d3d-e053-2995a90a8d152024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP2236031d-8596-4c21-8b16-83aa3e4122c12024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93e129c8-64c4-1f6d-e053-2a95a90ac1f82024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPe90d4ef3-8b90-41b7-bf96-340852e89b5f2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMedsource Pharmaceuticals12f113b3-d6b1-a7b0-e063-6294a90a999d2024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEMedsource Pharmaceuticals1278980b-4068-df57-e063-6394a90a87422024-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDELupin Pharmaceuticals, Inc.3e0ccb95-3e8e-477c-b4d2-6060ee05f9302023-12-11Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc2023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETruPharma, LLCaea56ff9-94ac-47a8-8f15-8790d538973b2023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP0bff5535-0239-409e-8a2a-99d5ba38cca32022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP00b7f61b-5173-43e6-a3f9-d2efbda40c192022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.dce0d21e-e4c2-4875-a2ce-9d53df190b802022-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP3c187736-ea96-4e59-9fe6-cb625a619c632022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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