FDA.reportPublic FDA data

NDC 80425-0141-01 - Tramadol HCL ER

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
80425-0141
Requested NDC
80425-0141-01
Package NDCs from labels
80425-0141-2, 80425-0141-1, 80425-0141-3, 80425-0141-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-11-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol HCL ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-11-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0141-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE308
80425-0141-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE608
80425-0141-3Tramadol HCLER90 in 1 BOTTLETABLET, EXTENDED RELEASE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0141TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20241124_c197f4e4-9ea5-562b-e053-2a95a90a975c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0141-1EA - Each80425-0141fa90fe3d-d6ee-4b53-b948-e0ba90737cea12023-03-13
80425-0141-2EA - Each80425-0141c6054659-dca5-4e2e-b2b7-10fc839ecb5b12023-03-13
80425-0141-3EA - Each80425-014146ba148a-296e-44a3-80fc-6ad449bab8b812024-12-10

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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP3c187736-ea96-4e59-9fe6-cb625a619c632022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833713
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP27495d02-8641-4c92-b5a3-edf50abc2a6f2022-05-02Warnings, Adverse reactionsExact identifier
application number: ANDA201384
rxcui: 833709
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP68646295-49b2-45ac-bf19-99bb91f7333d2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201384
rxcui: 833713
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPf63facd7-519b-4e2b-b54f-c17fc9ede55f2022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmneal Pharmaceuticals LLC58b802cb-2443-4f5b-9718-7d54c6d50cb42021-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETRUPHARMA LLC61fb5ba7-6896-4ee4-83de-caee69b06a8e2021-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LP1ad89537-3e59-438c-b646-b3c93b7908532021-01-01Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.82d8b70f-aebf-4b9a-89b1-183fc9e2ff592020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP50f4b752-20af-4ebf-9408-e78f30d2a3cc2019-11-01Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e2019-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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