50580-449 NDC - TYLENOL EXTRA STRENGTH (ACETAMINOPHEN)

Drug Information

Product NDC: 50580-449

Proprietary Name: TYLENOL Extra Strength

Non Proprietary Name: Acetaminophen

Active Ingredient(s):
  • 500 mg/1 ACETAMINOPHEN


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Labeler Information

Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Product Type: HUMAN OTC DRUG
FDA Application Number: part343
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:8/19/1984

Package Information

No. Package Code Package Description Billing Unit
150580-449-001 BOTTLE, PLASTIC in 1 CARTON (50580-449-00) / 125 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
250580-449-051 BOTTLE, PLASTIC in 1 CARTON (50580-449-05) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
350580-449-082 TABLET, FILM COATED in 1 POUCH (50580-449-08)
450580-449-091 BOTTLE, PLASTIC in 1 CARTON (50580-449-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
550580-449-1050 POUCH in 1 TRAY (50580-449-10) / 2 TABLET, FILM COATED in 1 POUCHEA
650580-449-1150 POUCH in 1 TRAY (50580-449-11) / 2 TABLET, FILM COATED in 1 POUCH
750580-449-1212 VIAL, PLASTIC in 1 PACKAGE (50580-449-12) / 10 TABLET, FILM COATED in 1 VIAL, PLASTICEA
850580-449-133 POUCH in 1 CARTON (50580-449-13) / 2 TABLET, FILM COATED in 1 POUCHEA
950580-449-142 TABLET, FILM COATED in 1 POUCH (50580-449-14)
1050580-449-1510 TABLET, FILM COATED in 1 VIAL, PLASTIC (50580-449-15)EA
1150580-449-231 BOTTLE, PLASTIC in 1 CARTON (50580-449-23) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1250580-449-311 BOTTLE, PLASTIC in 1 CARTON (50580-449-31) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1350580-449-34325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-449-34)
1450580-449-351 BOTTLE, PLASTIC in 1 CARTON (50580-449-35) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1550580-449-361 BOTTLE, PLASTIC in 1 CARTON (50580-449-36) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1650580-449-611 BOTTLE, PLASTIC in 1 CARTON (50580-449-61) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1750580-449-62325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-449-62)
1850580-449-842 TABLET, FILM COATED in 1 POUCH (50580-449-84)
1950580-449-8550 POUCH in 1 TRAY (50580-449-85) / 2 TABLET, FILM COATED in 1 POUCH
2050580-449-8650 POUCH in 1 TRAY (50580-449-86) / 2 TABLET, FILM COATED in 1 POUCH
2150580-449-873 POUCH in 1 CARTON (50580-449-87) / 2 TABLET, FILM COATED in 1 POUCH
2250580-449-961 BOTTLE in 1 CARTON (50580-449-96) / 50 TABLET, FILM COATED in 1 BOTTLE
2350580-449-97249 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-449-97)
2450580-449-98110 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-449-98)

NDC Record

Field Name Field Value Definition
PRODUCT NDC50580-449The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMETYLENOL Extra StrengthThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAcetaminophenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/19/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart343This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHENAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH500 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 2/1/2023