0573-0154 NDC - ADVIL (IBUPROFEN)

Drug Information

Product NDC: 0573-0154

Proprietary Name: ADVIL

Non Proprietary Name: ibuprofen

Active Ingredient(s):
  • 200 mg/1 IBUPROFEN


Administration Route(s): ORAL

Dosage Form(s): TABLET, COATED

Pharmacy Class(es):
  • Anti-Inflammatory Agents;
  • Non-Steroidal [CS];
  • Cyclooxygenase Inhibitors [MoA];
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA018989
Marketing Category: NDA
Start Marketing Date:5/18/1984

Package Information

No. Package Code Package Description Billing Unit
10573-0154-163 POUCH in 1 CARTON (0573-0154-16) / 2 TABLET, COATED in 1 POUCH
20573-0154-173000 POUCH in 1 CASE (0573-0154-17) / 2 TABLET, COATED in 1 POUCHEA
30573-0154-21200 TABLET, COATED in 1 BOTTLE (0573-0154-21)EA
40573-0154-351 BOTTLE in 1 CARTON (0573-0154-35) / 150 TABLET, COATED in 1 BOTTLEEA
50573-0154-591 BOTTLE in 1 CARTON (0573-0154-59) / 200 TABLET, COATED in 1 BOTTLE
60573-0154-60360 TABLET, COATED in 1 BOTTLE (0573-0154-60)
70573-0154-751 BOTTLE in 1 CARTON (0573-0154-75) / 200 TABLET, COATED in 1 BOTTLEEA
80573-0154-841 BOTTLE in 1 CARTON (0573-0154-84) / 225 TABLET, COATED in 1 BOTTLE
90573-0154-8950 POUCH in 1 CASE (0573-0154-89) / 2 TABLET, COATED in 1 POUCHEA
100573-0154-98300 TABLET, COATED in 1 BOTTLE (0573-0154-98)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0573-0154The 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 NAMEADVILThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEibuprofenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, 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 DATE5/18/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA018989This 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 NAMEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIBUPROFENAn 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 STRENGTH200 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] 

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