NDC 76519-1142

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 H.j. Harkins Company, Inc.. The primary component is Tramadol Hydrochloride.

Product ID76519-1142_73e6ec2d-2520-fe20-e053-2991aa0aa037
NDC76519-1142
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE ER
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA201384
Labeler NameH.J. Harkins Company, Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76519-1142-6

60 TABLET, EXTENDED RELEASE in 1 VIAL, PLASTIC (76519-1142-6)
Marketing Start Date2016-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1142-6 [76519114206]

TRAMADOL HYDROCHLORIDE ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-15
Inactivation Date2020-01-31

NDC 76519-1142-3 [76519114203]

TRAMADOL HYDROCHLORIDE ER TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:7395c20e-2c85-eb95-e053-2991aa0ab760
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
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