NDC 13811-691

Tramadol Hydrochloride Extended-Release

Tramadol Hydrochloride

Tramadol Hydrochloride Extended-Release is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Trigen Laboratories, Llc. The primary component is Tramadol Hydrochloride.

Product ID13811-691_288e149c-00a7-422b-bbb3-615d92cc5948
NDC13811-691
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride Extended-Release
Generic NameTramadol Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-06-22
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022370
Labeler NameTrigen Laboratories, LLC
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13811-691-30

30 CAPSULE in 1 BOTTLE, PLASTIC (13811-691-30)
Marketing Start Date2015-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13811-691-30 [13811069130]

Tramadol Hydrochloride Extended-Release CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022370
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-22

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:c0bc7218-3fd0-4646-96f4-25355fc84aa9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148478
  • 1148489
  • 1148485

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Tramadol Hydrochloride Extended-Release" or generic name "Tramadol Hydrochloride"

    NDCBrand NameGeneric Name
    13811-691Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    13811-690Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    13811-689Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    60429-584Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    60429-583Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    60429-585Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    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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