NDC 61919-892

TRAMADOL HYDROCHLORIDE ER

Tramadol Hydrochloride

TRAMADOL HYDROCHLORIDE ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Tramadol Hydrochloride.

Product ID61919-892_349ebc5f-3eed-15ba-e054-00144ff88e88
NDC61919-892
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE ER
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA201384
Labeler NameDirectRX
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-892-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-892-30)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-892-30 [61919089230]

TRAMADOL HYDROCHLORIDE ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:c34a95e3-d508-428f-9022-19cc5a90b4ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833709
  • Pharmacological Class

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

    NDC Crossover Matching brand name "TRAMADOL HYDROCHLORIDE ER" or generic name "Tramadol Hydrochloride"

    NDCBrand NameGeneric Name
    76519-1142TRAMADOL HYDROCHLORIDE ERTRAMADOL HYDROCHLORIDE ER
    61919-892TRAMADOL HYDROCHLORIDE ERTRAMADOL HYDROCHLORIDE 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.