55319-041 NDC - ACETAMINOPHEN

Drug Information

Product NDC: 55319-041

Proprietary Name: Acetaminophen

Non Proprietary Name: Acetaminophen

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


Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Labeler Information

Labeler Name: Family Dollar (FAMILY WELLNESS)
Product Type: HUMAN OTC DRUG
FDA Application Number: part343
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:7/31/2014

Package Information

No. Package Code Package Description Billing Unit
155319-041-101 BOTTLE in 1 BOX (55319-041-10) > 100 CAPSULE in 1 BOTTLE
255319-041-501 BOTTLE in 1 CARTON (55319-041-50) > 50 CAPSULE in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC55319-041The 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 NAMEAcetaminophenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXExtra StrengthA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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 NAMECAPSULEThe 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 DATE7/31/2014This 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 NAMEFamily Dollar (FAMILY WELLNESS)Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHENThis is the active ingredient list. Each 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: 9/13/2019