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 2 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepackacd5d8e0-a4cc-4654-ae04-faff347a60ca2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.007bf37f-0e46-426a-ac8c-be63d4b7414c2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol/APAPTRAMADOL/APAPDirect_rx4e40f55e-1d8e-ce2f-e063-6294a90a7bec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepacka77b0dba-8ac7-418a-b435-16a0e6c228042026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.b76c1366-f6c0-42ad-bb19-2b72a91490e42026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepacka886d551-6b57-4d9d-87f4-e1366385c7fd2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERising Pharma Holdings, Inc.b5852b90-e415-47ef-8f73-87266b58e0332026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELupin Pharmaceuticals, Inc.46bb9ae6-3ee8-463c-badb-c7a45a89b84b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutions4a525cf7-2c0c-47c6-aed3-3a395a7120ec2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutionsf9282800-fde7-477a-8b8f-59617ec26f732026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAsclemed USA, Inc.18d9e3e4-5892-43b8-b211-3ef3393ad9462026-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEGolden State Medical Supply, Inc.24aea499-c6f1-9200-e063-6394a90a9db62026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol Hydrochloride Extended-ReleaseTRAMADOL HYDROCHLORIDETrigen Laboratories, LLCc0bc7218-3fd0-4646-96f4-25355fc84aa92026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmneal Pharmaceuticals NY LLC67919c2c-2f8a-4bbb-bef5-0cd6c1e63a162026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076003
rxcui: 835603
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDERising Pharma Holdings, Inc.a63eadda-cabb-4f2c-86f9-2d8b4a2c88f32026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvagen Pharma Limited93b12089-3a0f-4b57-abb1-2429cf31995d2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCd51600e2-2f73-483c-9b2e-f142bafff16d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETeva Pharmaceuticals USA, Inc.561f00e5-f69c-4369-ae4d-5eff86c4499f2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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