NDC 47335-861

TRAMADOL HYDROCHLORIDE

Tramadol Hydrochloride

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

Product ID47335-861_19ed0b8b-df59-4d63-a437-835d2c7cc5eb
NDC47335-861
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA201384
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47335-861-08

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-08)
Marketing Start Date2011-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-861-83 [47335086183]

TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-12

NDC 47335-861-88 [47335086188]

TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-12

NDC 47335-861-08 [47335086108]

TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-12

NDC 47335-861-18 [47335086118]

TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-12

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:004de5a4-80f8-4040-a6ea-be5e99352a36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833711
  • 833713
  • 833709
    • UPC Code
  • 0347335861839
  • 0347335860832

    • Pharmacological Class

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

    Medicade Reported Pricing

    47335086183 TRAMADOL HCL ER 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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