NDC 45865-469

Tramadol Hydrochloride and Acetaminophen

Tramadol Hydrochloride And Acetaminophen

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

Product ID45865-469_1b67c155-5a0e-2202-e054-00144ff8d46c
NDC45865-469
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride and Acetaminophen
Generic NameTramadol Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA090485
Labeler NameMedsource Pharmaceuticals
Substance NameTRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength38 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45865-469-30

30 TABLET in 1 BOTTLE (45865-469-30)
Marketing Start Date2015-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-469-60 [45865046960]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA090485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-22

NDC 45865-469-40 [45865046940]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA090485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-22

NDC 45865-469-30 [45865046930]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA090485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-22

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:1b67c155-5a0d-2202-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836395

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Tramadol Hydrochloride and Acetaminophen" or generic name "Tramadol Hydrochloride And Acetaminophen"

    NDCBrand NameGeneric Name
    0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophen
    21695-236Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophen
    33261-389Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    33342-202Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    33358-343Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42254-051Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42291-832Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42571-119TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    45865-469Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    49884-946Tramadol hydrochloride and acetaminophentramadol hydrochloride and acetaminophen
    50090-0919Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50090-3248Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50090-3705TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    50268-774Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50436-6291Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    52959-814TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    53217-040Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    53217-180Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    55700-124Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    68071-3044Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68084-825Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68382-334Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68387-497Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68788-0985Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68788-9267Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    68788-9261TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    68788-9968Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    70518-1672Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    71335-0619Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    71335-0111Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    60429-500Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophen
    60505-2644Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophen
    60760-335Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    61919-067TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    61919-230TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    63187-084Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    63187-585Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    63629-4901Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    65162-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    65862-922Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    65841-758Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    21695-143ULTRACETtramadol hydrochloride and acetaminophen
    50458-650ULTRACETtramadol hydrochloride and acetaminophen
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