NDC 68387-900

Tramadol Hydrochloride

Tramadol Hydrochloride

Tramadol Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Tramadol Hydrochloride.

Product ID68387-900_d24bc5c8-18dc-40a6-b54f-7d4e20175950
NDC68387-900
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride
Generic NameTramadol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA076003
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-900-15

15 TABLET in 1 BOTTLE, PLASTIC (68387-900-15)
Marketing Start Date2009-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-900-30 [68387090030]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-90 [68387090090]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-20 [68387090020]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-12 [68387090012]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-40 [68387090040]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-24 [68387090024]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-60 [68387090060]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-50 [68387090050]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

NDC 68387-900-15 [68387090015]

Tramadol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-30
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:340a7760-50b1-4825-9766-eaaad0dd7712
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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