NDC 55700-412

TRAMADOL HYDROCHLORIDE

Tramadol Hydrochloride

TRAMADOL HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Tramadol Hydrochloride.

Product ID55700-412_0c8251a3-51ca-4eb9-bc91-6c538c480df2
NDC55700-412
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE
Generic NameTramadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA091498
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55700-412-01

120 TABLET, FILM COATED in 1 BOTTLE (55700-412-01)
Marketing Start Date2016-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-412-40 [55700041240]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-18 [55700041218]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-30 [55700041230]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-60 [55700041260]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-12 [55700041212]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-01 [55700041201]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-20 [55700041220]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-24 [55700041224]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-15 [55700041215]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

NDC 55700-412-08 [55700041208]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-27
Marketing End Date2019-02-21

NDC 55700-412-90 [55700041290]

TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-03

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:a7f11004-b6fa-4c12-abe5-68909b352f04
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.