NDC 52959-688

TRAMADOL HYDROCHLORIDE

Tramadol Hydrochloride

TRAMADOL HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Tramadol Hydrochloride.

Product ID52959-688_5d544cbc-94c2-6194-e053-2991aa0ada36
NDC52959-688
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE
Generic NameTramadol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA090404
Labeler NameH.J. Harkins Company Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-688-50

50 TABLET in 1 CONTAINER (52959-688-50)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-688-10 [52959068810]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-15 [52959068815]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-50 [52959068850]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-00 [52959068800]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-28 [52959068828]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-30 [52959068830]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-20 [52959068820]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-21 [52959068821]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-40 [52959068840]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-60 [52959068860]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-02 [52959068802]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-688-90 [52959068890]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA090404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:5d544cbc-94c1-6194-e053-2991aa0ada36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835603

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-3280TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-1978Tramadol HydrochlorideTramadol Hydrochloride
    68071-3321TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4119Tramadol HydrochlorideTramadol Hydrochloride
    68071-4165TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4154TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4070TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68071-4282tramadol hydrochloridetramadol hydrochloride
    68084-808Tramadol HydrochlorideTramadol Hydrochloride
    68071-4802tramadol hydrochloridetramadol hydrochloride
    68094-017Tramadol HydrochlorideTramadol Hydrochloride
    68180-698TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68180-699TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68180-697TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68258-2003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68382-319TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68387-900Tramadol HydrochlorideTramadol Hydrochloride
    68788-7321tramadol hydrochloridetramadol hydrochloride
    68788-9199Tramadol HydrochlorideTramadol Hydrochloride
    68788-6929TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-8921TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-7284Tramadol HydrochlorideTramadol Hydrochloride
    68788-7373TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-8920Tramadol HydrochlorideTramadol Hydrochloride
    68788-9232TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    68788-9237TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
    69150-020Tramadol HydrochlorideTramadol Hydrochloride
    69420-5150Tramadol HydrochlorideTramadol Hydrochloride
    69467-1001Tramadol HydrochlorideTramadol Hydrochloride
    69543-136Tramadol HydrochlorideTramadol Hydrochloride
    69677-316Tramadol HydrochlorideTramadol Hydrochloride
    70518-0054Tramadol HydrochlorideTramadol Hydrochloride
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