FDA.reportPublic FDA data

NDC 80425-0057-01 - Tramadol HCL

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
80425-0057
Requested NDC
80425-0057-01
Package NDCs from labels
80425-0057-5, 80425-0057-4, 80425-0057-1, 80425-0057-2, 80425-0057-3, 80425-0057-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol HCL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0057-1Tramadol HCL30 in 1 BOTTLETABLET, COATED309
80425-0057-2Tramadol HCL60 in 1 BOTTLETABLET, COATED609
80425-0057-3Tramadol HCL90 in 1 BOTTLETABLET, COATED909
80425-0057-4Tramadol HCL15 in 1 BOTTLETABLET, COATED159
80425-0057-5Tramadol HCL120 in 1 BOTTLETABLET, COATED1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0057TRAMADOL HCL TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af87fc31-07c2-b1f7-e053-2995a90a499f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0057-1EA - Each80425-0057504be37b-91ad-4507-a4aa-1f8cd3a6f86212023-03-13
80425-0057-2EA - Each80425-00574c02de54-897e-4e5b-ac17-54b2b024bb7912023-03-13
80425-0057-3EA - Each80425-0057ad860459-e36b-4269-87a3-ee63a4811db712023-03-13
80425-0057-4EA - Each80425-005753aa85da-c9bb-42b1-93bb-fd4d2d165c8512023-03-13
80425-0057-5EA - Each80425-0057998304a3-5bc5-44c3-ab3d-2e3b4e522fae12023-03-13

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 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2e738ced-9cde-e776-e063-6294a90a7e332025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEClinical Solutions Wholesale, LLC728157e2-d153-4ea0-81eb-36599dc7dfda2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.5babcfcf-331b-5db9-e053-2a91aa0aaf892025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
rxcui: 835603
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCL ERDirect_Rx09a7af47-423a-1e8b-e063-6394a90a99ef2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRxd5685c80-c84d-d0a1-e053-2995a90afc542025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXb3c702f7-0a8c-a52b-e053-2995a90a6df32025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.1e79e1fa-3473-f4a7-e063-6294a90a95762025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPd7e75fd3-18d1-4370-bb63-c9dd8a2c17192025-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDECranbury Pharmaceuticals, LLC1d4af58f-17f3-4cbd-870c-098ace9548722024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HCLTRAMADOL HCLAdvanced Rx of Tennessee, LLCaf87fc31-07c2-b1f7-e053-2995a90a499f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
ndc (package): 80425-0057-1
ndc (package): 80425-0057-5
ndc (package): 80425-0057-4
ndc (package): 80425-0057-2
ndc (package): 80425-0057-3
ndc (product): 80425-0057
ndc11 (package): 80425005701
rxcui: 835603
spl id: 2a98da36-e8b2-759b-e063-6294a90ab33b
spl set id: af87fc31-07c2-b1f7-e053-2995a90a499f
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCbf51a3af-cbc6-3021-e053-2a95a90a80b72024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCbba287fe-fbf6-65a9-e053-2a95a90a92372024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4ea18b0-2cbd-0d42-e053-2995a90a92642024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCf8c5328d-7b47-626e-e053-6294a90a04b32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEQuality Care Products, LLCf79fda81-f09a-4a08-babc-6bd3bb3ee6612024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC68484531-f908-473f-a422-f37234de96912024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC7e421fb6-737c-49b3-b299-50511e281a4d2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCc197f4e4-9ea5-562b-e053-2a95a90a975c2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCb4cd4b64-7db5-da44-e053-2995a90a89532024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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