NDC 33261-105

Tramadol Hydrochloride

Tramadol Hydrochloride

Tramadol Hydrochloride is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Tramadol Hydrochloride.

Product ID33261-105_1dcbca44-a8e9-47a2-8c61-2758dd586a83
NDC33261-105
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride
Generic NameTramadol Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2010-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA076003
Labeler NameAidarex Pharmaceuticals LLC
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 33261-105-20

20 TABLET, COATED in 1 BOTTLE (33261-105-20)
Marketing Start Date2010-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-105-99 [33261010599]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-00 [33261010500]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-91 [33261010591]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-09 [33261010509]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-02 [33261010502]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-04 [33261010504]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-60 [33261010560]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-40 [33261010540]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-45 [33261010545]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-20 [33261010520]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-90 [33261010590]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-15 [33261010515]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-16 [33261010516]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-50 [33261010550]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-98 [33261010598]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-30 [33261010530]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 33261-105-10 [33261010510]

Tramadol Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:ac536879-c38b-4012-ae72-655ff9866691
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.