NDC 12634-786

TRAMADOL HYDROCHLORIDE

Tramadol Hydrochloride

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

Product ID12634-786_2709bacb-b51c-124d-e054-00144ff88e88
NDC12634-786
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE
Generic NameTramadol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA076003
Labeler NameAPOTHECA, 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 12634-786-62

2 TABLET in 1 BLISTER PACK (12634-786-62)
Marketing Start Date2010-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-786-90 [12634078690]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-62 [12634078662]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-52 [12634078652]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-96 [12634078696]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-00 [12634078600]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-80 [12634078680]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-66 [12634078666]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-71 [12634078671]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-54 [12634078654]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-91 [12634078691]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-60 [12634078660]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-79 [12634078679]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-59 [12634078659]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-01 [12634078601]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-65 [12634078665]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-55 [12634078655]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-61 [12634078661]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-85 [12634078685]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-57 [12634078657]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-36 [12634078636]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Marketing End Date2016-01-26

NDC 12634-786-81 [12634078681]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

NDC 12634-786-50 [12634078650]

TRAMADOL HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:dddcfc5c-e97c-494d-ab17-046455abbb4a
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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