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 7 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP27495d02-8641-4c92-b5a3-edf50abc2a6f2022-05-02Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP68646295-49b2-45ac-bf19-99bb91f7333d2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPf63facd7-519b-4e2b-b54f-c17fc9ede55f2022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmneal Pharmaceuticals LLC58b802cb-2443-4f5b-9718-7d54c6d50cb42021-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETRUPHARMA LLC61fb5ba7-6896-4ee4-83de-caee69b06a8e2021-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LP1ad89537-3e59-438c-b646-b3c93b7908532021-01-01Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.82d8b70f-aebf-4b9a-89b1-183fc9e2ff592020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP50f4b752-20af-4ebf-9408-e78f30d2a3cc2019-11-01Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e2019-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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