NDC 51655-185

Ultram

Tramadol Hcl

Ultram is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Tramadol Hydrochloride.

Product ID51655-185_39dcdd81-7699-4582-8a85-f763d7d73e18
NDC51655-185
Product TypeHuman Prescription Drug
Proprietary NameUltram
Generic NameTramadol Hcl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2014-02-13
Marketing CategoryANDA / ANDA
Application NumberANDA076003
Labeler NameNORTHWIND PHARMACEUTICALS
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/201
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 51655-185-20

20 TABLET, COATED in 1 BOTTLE (51655-185-20)
Marketing Start Date2014-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-185-20 [51655018520]

Ultram TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/201

OpenFDA Data

SPL SET ID:3f12e8b3-ccf5-4b7d-a370-9596e5002b10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835605
  • 835603
    • UPC Code
  • 0516550185208

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Ultram" or generic name "Tramadol Hcl"

    NDCBrand NameGeneric Name
    50458-659ULTRAMtramadol hydrochloride
    51655-185UltramTRAMADOL HCL
    80425-0057UltramTramadol HCl 50mg
    80425-0058UltramTramadol HCl 50mg
    80425-0108UltramTramadol HCl 100mg
    80425-0141UltramTramadol 100mg
    80425-0159UltramTramadol 50mg
    51655-182Tramadol HClTramadol HCl
    61919-818TRAMADOL HCLTRAMADOL HCL
    80425-0101Tramadol HCLTramadol HCL
    80425-0127Tramadol HCLTramadol HCL
    80425-0136Tramadol HCLTramadol HCL

    Trademark Results [Ultram]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ULTRAM
    ULTRAM
    73811654 1583293 Live/Registered
    JOHNSON & JOHNSON
    1989-07-10
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.