NDC 21695-563

ULTRAM ER

Tramadol Hydrochloride

ULTRAM ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Tramadol Hydrochloride.

Product ID21695-563_2fd193e2-7aa7-4119-b540-7e28e82fbd13
NDC21695-563
Product TypeHuman Prescription Drug
Proprietary NameULTRAM ER
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2005-09-08
Marketing CategoryNDA / NDA
Application NumberNDA021692
Labeler NameRebel Distributors Corp
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-563-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-563-30)
Marketing Start Date2005-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-563-30 [21695056330]

ULTRAM ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021692
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-09-08
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:2fd193e2-7aa7-4119-b540-7e28e82fbd13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 845314
  • 845315
  • 833711
  • 833713
  • 833709
  • 845316

    • Pharmacological Class

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

    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
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