FDA.reportPublic FDA data

NDC 80425-0501-01 - 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
80425-0501
Requested NDC
80425-0501-01
Package NDCs from labels
80425-0501-1, 80425-0501-2, 80425-0501-3, 80425-0501-4, 80425-0501-5, 80425-0501-7, 80425-0501-8, 80425-0501-6, 80425-0501-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0501-1Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED151
80425-0501-2Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED301
80425-0501-3Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED601
80425-0501-4Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED901
80425-0501-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1201
80425-0501-6Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED401
80425-0501-7Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1801
80425-0501-8Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0501TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 8 package rows20250221_2e738ced-9cde-e776-e063-6294a90a7e33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0501-1EA - Each80425-05015b367eca-98d7-4034-a218-38197df636e712025-03-04
80425-0501-2EA - Each80425-0501b9cf99f9-897c-4f4f-94f6-3ccaf4f83a9212025-03-04
80425-0501-3EA - Each80425-0501b7c9bbe8-370c-428d-b7d8-916758373a8912025-03-04
80425-0501-4EA - Each80425-0501756c208b-56a5-4df6-9f17-65c41677bde512025-03-04
80425-0501-5EA - Each80425-05011f8064f3-66bb-4859-850f-f42fbc72a96c12025-03-04
80425-0501-6EA - Each80425-0501f406d2e2-a3ba-40aa-a5a7-fa458eceb81e12025-03-04
80425-0501-7EA - Each80425-05016f965c02-75e5-44aa-b55a-feb03d48262612025-03-04
80425-0501-8EA - Each80425-0501bf6a096b-a9fc-4ba5-92c8-38303e66a4ab12025-03-04

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 109 · 2,167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC552955e6-2bb3-8755-e063-6394a90ab21c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC54d74939-301b-e603-e063-6394a90a3b032026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
rxcui: 835603
unii: 9N7R477WCK
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack515baa9a-b226-4bbe-be87-f9befdf1c9e12026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.5199132e-745e-46a0-8068-e06d1bca5c612026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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