NDC 80425-0274-01 - Tramadol Hydrochloride

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
80425-0274
Requested NDC
80425-0274-01
Package NDCs from labels
80425-0274-1, 80425-0274-2, 80425-0274-3, 80425-0274-4, 80425-0274-5, 80425-0274-6, 80425-0274-7, 80425-0274-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0274-1Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED153
80425-0274-2Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED303
80425-0274-3Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED603
80425-0274-4Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED903
80425-0274-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1203
80425-0274-6Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED403
80425-0274-7Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0274TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 7 package rows20240910_f44c53ec-26ea-d272-e053-2a95a90a5e59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0274-1EA - Each80425-0274398555b3-0411-47e6-9afb-1aebc5e4819412023-04-07
80425-0274-2EA - Each80425-02745a329e9a-dd9d-46d4-9b10-8def9a2acc1912023-04-07
80425-0274-3EA - Each80425-02747b68ac6b-df12-4650-a322-60af28fd374f12023-04-07
80425-0274-4EA - Each80425-0274b5316944-76e0-4461-a650-fa097b34967312023-04-07
80425-0274-5EA - Each80425-0274809f47ab-f58f-44b4-bed7-4b231ac0d99612023-04-07
80425-0274-6EA - Each80425-0274d94d1f4f-7837-432c-8290-0aa300c428e612023-04-07
80425-0274-7EA - Each80425-02740429d619-0f6b-4a38-a6c3-604e9aeb100212024-07-12

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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConZipTRAMADOL HYDROCHLORIDEVertical Pharmaceuticals, LLCa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC1b5360f8-3e95-a047-e063-6294a90a73152025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3d719560-7449-f970-e063-6294a90a9bd82025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
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
application number: ANDA208708
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.f558c59c-cbd4-4b17-9a3d-b014ad09bbb12025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
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
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.c30f6e9e-8014-40fc-9615-a6b8654137c12025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.84b12129-cf10-4a3e-889c-990ebabdece62025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208708
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.e6e275c3-1e16-4a00-b7fd-608ae6cbd5152025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack2bf66203-8b45-475d-9a70-4d7c8bdfe6b32025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208708
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEA-S Medication Solutionsc28c98ac-7e07-46a5-8f34-57c008308fba2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmerican Health Packagingf6f6069b-cc75-4b87-afa5-b83001b543e02025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAsclemed USA, Inc.6a60bd36-7dcc-49c3-b6de-b263fdaa312c2025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208708
rxcui: 2670390
rxcui: 835603
rxcui: 2179635
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC3135a131-5f2d-3775-e063-6394a90a43222025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208708
rxcui: 2179635
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDECoupler LLC2f23ba6c-89d2-cc42-e063-6394a90aee0a2025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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