NDC 50580-309

Tylenol 8HR

Acetaminophen

Tylenol 8HR is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen.

Product ID50580-309_169f82b9-f989-4f24-aed0-09578d027a7f
NDC50580-309
Product TypeHuman Otc Drug
Proprietary NameTylenol 8HR
Generic NameAcetaminophen
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-01-18
Marketing CategoryNDA / NDA
Application NumberNDA019872
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN
Active Ingredient Strength650 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50580-309-01

1 BOTTLE in 1 CARTON (50580-309-01) > 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2016-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-309-01 [50580030901]

Tylenol 8HR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-18

NDC 50580-309-02 [50580030902]

Tylenol 8HR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-01-18

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:5d7d1300-bcb8-466a-880b-310b360ee132
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148399
  • 1243440
  • UPC Code
  • 0300450297211
  • NDC Crossover Matching brand name "Tylenol 8HR" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    50580-309Tylenol 8HRTylenol 8HR
    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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