FDA.reportPublic FDA data

NDC 80425-0108-01 - 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
80425-0108
Requested NDC
80425-0108-01
Package NDCs from labels
80425-0108-2, 80425-0108-1, 80425-0108-3, 80425-0108-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-11-20
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, LLC2024-11-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0108-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE307
80425-0108-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE607
80425-0108-3Tramadol HCLER90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0108TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20241123_b4cd4b64-7db5-da44-e053-2995a90a8953.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0108-1EA - Each80425-01084732e417-9029-4e51-a84c-54025ecb45d912023-03-13
80425-0108-2EA - Each80425-01086cfc6ff4-1f55-418d-b8c9-a21bde8197f012023-03-13
80425-0108-3EA - Each80425-0108b5c80406-51df-4df5-9bc9-f3bf5c4c6d6112024-12-10

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 1 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.c6104e62-5b2c-41a1-afb3-00dcf267a3842026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEStrides Pharma Science Limiteda6cbd5de-8ae5-49e3-b89b-e35536b115d82026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAurobindo Pharma Limitede5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.16053b28-c759-4914-93e6-2de0afe724452026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy42de8c3a-0441-5d46-e063-6294a90a20792026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.6bb5be12-59ff-40f4-9841-9c7ab93be2ea2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacycb05d615-918d-8104-e053-2995a90aa96b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC552e5b32-accf-29dd-e063-6294a90a4fcf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC552955e6-2bb3-8755-e063-6394a90ab21c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC54d74939-301b-e603-e063-6394a90a3b032026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack515baa9a-b226-4bbe-be87-f9befdf1c9e12026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.5199132e-745e-46a0-8068-e06d1bca5c612026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.855905c7-1481-4b2d-a318-3254ad8ed73c2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPaefc85bc-0820-4aee-8d94-313c5f1658f52026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEMajor Pharmaceuticals6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackccf465b5-8ef8-4445-a0d4-23b5cf13188c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack66359f41-9999-4cb8-b632-1fe2ec1e60b22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack43fe10b2-17a4-4dc2-9a48-2378547b61fd2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYf2f421ab-35ae-7637-e053-2995a90a40e02026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack674803a0-4cf5-4416-a5e3-c1a1e332cdcd2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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