NDC 50458-655

Ultram ER

Tramadol Hydrochloride

Ultram ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, . The primary component is Tramadol Hydroc.

Product ID50458-655_96bec1b6-7ff2-4e89-be58-d5c359fb51f4
NDC50458-655
Product TypeHuman Prescription Drug
Proprietary NameUltram ER
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2005-10-01
Marketing CategoryNDA / NDA
Application NumberNDA021692
Labeler NameJanssen Pharmaceuticals,
Substance NameTRAMADOL HYDROC
Active Ingredient Strength200 mg/1
Pharm ClassesFull Opioid Ago
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 50458-655-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50458-655-30)
Marketing Start Date2005-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-655-30 [50458065530]

Ultram ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021692
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-10-01
Marketing End Date2016-04-30

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:039f9e7c-97f5-4062-8656-6f355c82008e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 845314
  • 845315
  • 833711
  • 833713
  • 833709
  • 845316
    • UPC Code
  • 0350458657302
  • 0350458655308
  • 0350458653304

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    Medicade Reported Pricing

    50458065530 ULTRAM ER 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Ultram ER" or generic name "Tramadol Hydrochloride"

    NDCBrand NameGeneric Name
    21695-913ULTRAM ERULTRAM ER
    21695-563ULTRAM ERULTRAM ER
    21695-292ULTRAM ERULTRAM ER
    50458-653Ultram ERUltram ER
    50458-655Ultram ERUltram ER
    50458-657Ultram ERUltram ER
    0093-0058Tramadol HydrochlorideTramadol Hydrochloride
    0378-4151Tramadol Hydrochloridetramadol hydrochloride
    0378-4152Tramadol Hydrochloridetramadol hydrochloride
    0378-4153Tramadol Hydrochloridetramadol hydrochloride
    0378-4154Tramadol Hydrochloridetramadol hydrochloride
    0615-7810Tramadol Hydrochloridetramadol hydrochloride
    0615-8005Tramadol HydrochlorideTramadol Hydrochloride
    0904-6365TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    0904-7179tramadol hydrochloridetramadol hydrochloride
    10147-0901TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10147-0902TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10147-0903TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    10370-221Tramadol Hydrochloridetramadol hydrochloride
    10370-222Tramadol HydrochlorideTramadol Hydrochloride
    10370-223Tramadol HydrochlorideTramadol Hydrochloride
    10544-009Tramadol HydrochlorideTramadol Hydrochloride
    10544-531Tramadol HydrochlorideTramadol Hydrochloride
    12634-786TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.