80513-230 NDC - PURGENLABS ACETAMINOPHEN (ACTAMINOPHEN)

Drug Information

  • Product NDC: 80513-230
  • Proprietary Name: PurgenLabs Acetaminophen
  • Non Proprietary Name: Actaminophen
  • Active Ingredient(s): 500 mg/15mL ACETAMINOPHEN
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID

Labeler Information

Field Name Field Value
Labeler Name: Advanced Rx LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: M012
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:6/1/2024

Package Information

No. Package Code Package Description Billing Unit
180513-230-081 BOTTLE in 1 CARTON (80513-230-08) / 237 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC80513-230The 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 DRUGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEPurgenLabs AcetaminophenThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEActaminophenThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAMELIQUIDProduct 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.
ROUTE NAMEORALThis 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.
START MARKETING DATE6/1/2024Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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 NUMBERM012This 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 NAMEAdvanced Rx LLCName 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/15mL 

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This page was last updated on: 7/4/2025

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