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 2 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack43fe10b2-17a4-4dc2-9a48-2378547b61fd2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYf2f421ab-35ae-7637-e053-2995a90a40e02026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack674803a0-4cf5-4416-a5e3-c1a1e332cdcd2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepackacd5d8e0-a4cc-4654-ae04-faff347a60ca2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.007bf37f-0e46-426a-ac8c-be63d4b7414c2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol/APAPTRAMADOL/APAPDirect_rx4e40f55e-1d8e-ce2f-e063-6294a90a7bec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepacka77b0dba-8ac7-418a-b435-16a0e6c228042026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.b76c1366-f6c0-42ad-bb19-2b72a91490e42026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepacka886d551-6b57-4d9d-87f4-e1366385c7fd2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERising Pharma Holdings, Inc.b5852b90-e415-47ef-8f73-87266b58e0332026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELupin Pharmaceuticals, Inc.46bb9ae6-3ee8-463c-badb-c7a45a89b84b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutions4a525cf7-2c0c-47c6-aed3-3a395a7120ec2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutionsf9282800-fde7-477a-8b8f-59617ec26f732026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAsclemed USA, Inc.18d9e3e4-5892-43b8-b211-3ef3393ad9462026-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEGolden State Medical Supply, Inc.24aea499-c6f1-9200-e063-6394a90a9db62026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride Extended-ReleaseTRAMADOL HYDROCHLORIDETrigen Laboratories, LLCc0bc7218-3fd0-4646-96f4-25355fc84aa92026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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