NDC 68387-497

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 Keltman Pharmaceuticals Inc.. The primary component is Tramadol Hydrochloride; Acetaminophen.

Product ID68387-497_daef6ebf-66a8-4909-90e1-20d39ed5ed20
NDC68387-497
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride and Acetaminophen
Generic NameTramadol Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA076475
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameTRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength38 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-497-20

20 TABLET in 1 BOTTLE, PLASTIC (68387-497-20)
Marketing Start Date2009-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-497-30 [68387049730]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-07
Inactivation Date2019-10-21

NDC 68387-497-90 [68387049790]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-07
Inactivation Date2019-10-21

NDC 68387-497-12 [68387049712]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-19
Inactivation Date2019-10-21

NDC 68387-497-20 [68387049720]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-19
Inactivation Date2019-10-21

NDC 68387-497-60 [68387049760]

Tramadol Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-07
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:80aaf81a-3447-4977-8902-03c62528a526
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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