FDA.reportPublic FDA data

Durela

Manufacturer
Galephar Pharmaceutical Research Inc.
Effective date
2024-12-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:19:01

Label at a glance#

ProductDurela
Active ingredientTRAMADOL HYDROCHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

Durela 100 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Durela 100 mg_30 capsDurela 100 mg_30 caps

Durela 200 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Durela 200 mg_Bottle of 30 capsDurela 200 mg_Bottle of 30 caps

Durela 300 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Durela 300 mg_capsulesDurela 300 mg_capsules

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TRAMADOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66277-239-30Durela30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
66277-241-30Durela30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
66277-242-30Durela30 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
66277-241DURELA (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]41 package rows20241208_d787c214-e8fe-1da1-e053-2a95a90a4288.zip
66277-242DURELA (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]41 package rows20241208_d787c214-e8fe-1da1-e053-2a95a90a4288.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66277-23966277-239-30
66277-24266277-242-30
66277-24166277-241-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K30U725QWY32XIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)P2OM2Q86BIIACT
SUCROSE STEARATE274KW0O50MIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TRAMADOL HYDROCHLORIDE9N7R477WCKACTIB
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)P2OM2Q86BIIACT
SUCROSE STEARATE274KW0O50MIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TRAMADOL HYDROCHLORIDE9N7R477WCKACTIB
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
POVIDONE K30U725QWY32XIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)P2OM2Q86BIIACT
SUCROSE STEARATE274KW0O50MIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TRAMADOL HYDROCHLORIDE9N7R477WCKACTIB
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
289d45e6-0e84-8aad-e063-6394a90ae853d787c214-e8fe-1da1-e053-2a95a90a42882024-12-06Exact identifier
spl id: 289d45e6-0e84-8aad-e063-6394a90ae853
spl set id: d787c214-e8fe-1da1-e053-2a95a90a4288

Reported adverse events (FAERS/openFDA)#

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