FDA.reportPublic FDA data

NDC 65162-127 - 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
65162-127
Package NDCs from labels
65162-127-10, 65162-127-50, 65162-127-11
Manufacturer
COREPHARMA LLC.
Effective date
2006-08-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAMADOL HYDROCHLORIDE TABLETS 50 mg Rx onlyCOREPHARMA LLC.2006-08-23Human Prescription Drug Labeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-127-10TRAMADOL HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
65162-127-11TRAMADOL HYDROCHLORIDE1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001
65162-127-50TRAMADOL HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-127TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]13 package rows20061012_C33601EC-EF89-4BD4-8485-F81871AFAD94.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
TramadolACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
hypromelloseINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
lactose monohydrateINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
microcrystalline celluloseINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
polyethylene glycolINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
polysorbate 80INACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
pregelatinized starchINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
sodium starch glycolateINACTIVE INGREDIENTTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, FILM COATED [COREPHARMA LLC.]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
C33601EC-EF89-4BD4-8485-F81871AFAD94C33601EC-EF89-4BD4-8485-F81871AFAD942006-08-23Warnings, Adverse reactionsExact identifier
spl id: C33601EC-EF89-4BD4-8485-F81871AFAD94
spl set id: C33601EC-EF89-4BD4-8485-F81871AFAD94

Reported adverse events (FAERS/openFDA)#

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