FDA.reportPublic FDA data

NDC 80425-0136-01 - 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
80425-0136
Requested NDC
80425-0136-01
Package NDCs from labels
80425-0136-2, 80425-0136-1, 80425-0136-01
Manufacturer
Advanced Rx Pharmacy 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 ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0136-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE307
80425-0136-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0136TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_bf51a3af-cbc6-3021-e053-2a95a90a80b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0136-1EA - Each80425-013678a447c1-8437-45f4-8b76-fd86717379e812023-06-06
80425-0136-2EA - Each80425-0136e683def1-db59-4788-8aed-086b2d35ace712023-03-13

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 5 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27460cc6-0782-7838-e063-6394a90a19f12024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack6ebc5864-c222-4400-a9b2-f66fd6fb0da62024-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HCL ERTRAMADOL HCLDIRECT RX5285f056-c32c-4e7a-bec6-3a726aa23d5a2024-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833709
rxcui: 833711
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals, Inc.1cd3caee-bf54-7aba-e063-6394a90ad8cb2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf44c53ec-26ea-d272-e053-2a95a90a5e592024-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackf33fcd05-2c95-48dd-884b-5ed9c25c2ccf2024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack8cc09b31-6067-44ec-8aba-ea7bb1a1f4482024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833709
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepackb2f3f007-6dda-4532-9f7f-d93f6e65254c2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93c9c960-afbf-6d3d-e053-2995a90a8d152024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833709
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP2236031d-8596-4c21-8b16-83aa3e4122c12024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93e129c8-64c4-1f6d-e053-2a95a90ac1f82024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPe90d4ef3-8b90-41b7-bf96-340852e89b5f2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMedsource Pharmaceuticals12f113b3-d6b1-a7b0-e063-6294a90a999d2024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEMedsource Pharmaceuticals1278980b-4068-df57-e063-6394a90a87422024-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDELupin Pharmaceuticals, Inc.3e0ccb95-3e8e-477c-b4d2-6060ee05f9302023-12-11Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
rxcui: 833709
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc2023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
rxcui: 833709
rxcui: 833711
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETruPharma, LLCaea56ff9-94ac-47a8-8f15-8790d538973b2023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP0bff5535-0239-409e-8a2a-99d5ba38cca32022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP00b7f61b-5173-43e6-a3f9-d2efbda40c192022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.dce0d21e-e4c2-4875-a2ce-9d53df190b802022-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833713
rxcui: 833709
rxcui: 833711
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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