NDC 36800-369

Topcare 8 Hour Pain Relief

Acetaminophen

Topcare 8 Hour Pain Relief is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen.

Product ID36800-369_0eabe054-e59f-4d27-b7a2-ccf6bc3a516a
NDC36800-369
Product TypeHuman Otc Drug
Proprietary NameTopcare 8 Hour Pain Relief
Generic NameAcetaminophen
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA075077
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN
Active Ingredient Strength650 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 36800-369-78

1 BOTTLE in 1 CARTON (36800-369-78) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2017-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-369-78 [36800036978]

Topcare 8 Hour Pain Relief TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075077
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-05

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:38abe710-3d8a-41b0-b057-38c5dfd53322
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148399
  • NDC Crossover Matching brand name "Topcare 8 Hour Pain Relief" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    36800-369Topcare 8 Hour Pain ReliefTopcare 8 Hour Pain Relief
    0121-0657AcetaminophenAcetaminophen
    0113-7000Basic Care acetaminophenAcetaminophen
    0113-7484basic care acetaminophenAcetaminophen
    0113-7544Basic Care AcetaminophenAcetaminophen
    0113-7130basic care childrens pain and feverAcetaminophen
    0113-0020good sense childrens pain and feverAcetaminophen
    0113-0212Good Sense Childrens Pain and FeverAcetaminophen
    0113-0608good sense childrens pain and feverAcetaminophen
    0113-0998Good Sense Childrens Pain and FeverAcetaminophen
    0113-0161Good Sense pain and feverAcetaminophen
    0113-0397Good Sense Pain and Feveracetaminophen
    0113-0590Good Sense Pain and Feveracetaminophen
    0113-0946good sense pain and feverAcetaminophen
    0113-8959Good Sense Pain and FeverAcetaminophen
    0113-0025Good Sense Pain ReliefAcetaminophen
    0113-0044Good Sense Pain ReliefAcetaminophen
    0113-0187good sense pain reliefAcetaminophen
    0113-0217good sense pain reliefAcetaminophen
    0113-0227Good Sense Pain ReliefAcetaminophen
    0113-0403good sense pain reliefAcetaminophen
    0113-0484Good Sense Pain ReliefAcetaminophen
    0113-0518good sense pain reliefAcetaminophen
    0113-0544good sense pain reliefAcetaminophen
    0113-1889good sense pain reliefacetaminophen
    0113-1975Good Sense Pain ReliefAcetaminophen
    0031-9301Robitussin Direct Sore Throat Painacetaminophen

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