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 3 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmneal Pharmaceuticals NY LLC67919c2c-2f8a-4bbb-bef5-0cd6c1e63a162026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERising Pharma Holdings, Inc.a63eadda-cabb-4f2c-86f9-2d8b4a2c88f32026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvagen Pharma Limited93b12089-3a0f-4b57-abb1-2429cf31995d2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCd51600e2-2f73-483c-9b2e-f142bafff16d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETeva Pharmaceuticals USA, Inc.561f00e5-f69c-4369-ae4d-5eff86c4499f2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
ConZipTRAMADOL HYDROCHLORIDEVertical Pharmaceuticals, LLCa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC1b5360f8-3e95-a047-e063-6294a90a73152025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3d719560-7449-f970-e063-6294a90a9bd82025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda07ed444-54e4-4d45-b6a1-6ea2f6dedc612025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.dc420d50-6192-482d-b3da-3be55870a79a2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.004de5a4-80f8-4040-a6ea-be5e99352a362025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAurobindo Pharma Limited6c2894df-eeeb-4b22-ab32-8ce1601bfdfa2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERedPharm Drug Incf4c148f3-845a-61e3-e053-2a95a90a326e2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.f558c59c-cbd4-4b17-9a3d-b014ad09bbb12025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.83367367-5654-4078-831a-69ade48bc7952025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.05f8e06b-f3eb-4cb2-aee5-bd0b038841782025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.c30f6e9e-8014-40fc-9615-a6b8654137c12025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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