FDA.reportPublic FDA data

NDC 0591-0466 - 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
0591-0466
Package NDCs from labels
0591-0466-01, 0591-0466-05, 0591-0466-10
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride Tablets Revised: August 2004 Rx only 30354-3Watson Laboratories, Inc.2007-03-30HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0466-01Tramadol HCl100 in 1 BOTTLETABLET1001
0591-0466-05Tramadol HCl500 in 1 BOTTLETABLET5001
0591-0466-10Tramadol HCl1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0466TRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]13 package rows20070426_AE7C54B1-B440-4CCA-97E8-E5B825413D32.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tramadol hydrochlorideACTIVE INGREDIENT9N7R477WCKTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
TramadolACTIVE MOIETY39J1LGJ30JTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
hypromelloseINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
lactose monohydrateINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
polyethylene glycolINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
polysorbateINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
pregelatinized starchINACTIVE INGREDIENTTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HCL (TRAMADOL HYDROCHLORIDE) TABLET [WATSON LABORATORIES, INC.]1

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDECranbury Pharmaceuticals, LLC1d4af58f-17f3-4cbd-870c-098ace9548722024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HCLTRAMADOL HCLAdvanced Rx of Tennessee, LLCaf87fc31-07c2-b1f7-e053-2995a90a499f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4ea18b0-2cbd-0d42-e053-2995a90a92642024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEQuality Care Products, LLCf79fda81-f09a-4a08-babc-6bd3bb3ee6612024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27460cc6-0782-7838-e063-6394a90a19f12024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack6ebc5864-c222-4400-a9b2-f66fd6fb0da62024-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
TRAMADOL HCL ERTRAMADOL HCLDIRECT RX5285f056-c32c-4e7a-bec6-3a726aa23d5a2024-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals, Inc.1cd3caee-bf54-7aba-e063-6394a90ad8cb2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf44c53ec-26ea-d272-e053-2a95a90a5e592024-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP2236031d-8596-4c21-8b16-83aa3e4122c12024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPe90d4ef3-8b90-41b7-bf96-340852e89b5f2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAmneal Pharmaceuticals LLC58b802cb-2443-4f5b-9718-7d54c6d50cb42021-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETRUPHARMA LLC61fb5ba7-6896-4ee4-83de-caee69b06a8e2021-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP50f4b752-20af-4ebf-9408-e78f30d2a3cc2019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 835603
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e2019-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
DCDBD628-2710-71BE-6C6C-C2783D12AAA0AE7C54B1-B440-4CCA-97E8-E5B825413D322007-03-30Warnings, Adverse reactionsExact identifier
spl id: DCDBD628-2710-71BE-6C6C-C2783D12AAA0
spl set id: AE7C54B1-B440-4CCA-97E8-E5B825413D32

Reported adverse events (FAERS/openFDA)#

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