NDC 0573-0164-45 Advil Pm
Diphenhydramine Citrate And Ibuprofen Tablet, Coated Oral

Package Information

The NDC Code 0573-0164-45 is assigned to a package of 1 bottle in 1 carton > 180 tablet, coated in 1 bottle of Advil Pm, a human over the counter drug labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is tablet, coated and is administered via oral form.

Field Name Field Value
NDC Code 0573-0164-45
Package Description 1 BOTTLE in 1 CARTON > 180 TABLET, COATED in 1 BOTTLE
Product Code 0573-0164
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Advil Pm
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Diphenhydramine Citrate And Ibuprofen
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This product is used as Nighttime sleep-aidPain reliever. For relief of occasional sleeplessness when associated with minor aches and painshelps you fall asleep and stay asleep
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
00573016445
NDC to RxNorm Crosswalk
  • RxCUI: 895664 - ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 895664 - diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet
  • Product Type What kind of product is this?
    Indicates 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.
    Human Otc Drug
    Labeler Name Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    Dosage Form Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s)
    • Oral - Administration to or by way of the mouth.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What is the Marketing Category?
    Product 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.
    NDA - A product marketed under an approved New Drug Application.
    FDA Application Number What is the FDA Application Number?
    This 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.
    NDA021394
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    12-21-2005
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2022
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC Code Structure

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Advil Pm with product NDC 0573-0164.

    NDC Package CodePackage Description
    0573-0164-044 TABLET, COATED in 1 POUCH
    0573-0164-052 BOTTLE in 1 CARTON > 2 TABLET, COATED in 1 BOTTLE
    0573-0164-081 VIAL in 1 PACKAGE > 8 TABLET, COATED in 1 VIAL
    0573-0164-098 TABLET, COATED in 1 VIAL
    0573-0164-126 POUCH in 1 CARTON > 2 TABLET, COATED in 1 POUCH
    0573-0164-142 POUCH in 1 CARTON > 2 TABLET, COATED in 1 POUCH
    0573-0164-201 BOTTLE in 1 CARTON > 20 TABLET, COATED in 1 BOTTLE
    0573-0164-211 BOTTLE in 1 CARTON > 30 TABLET, COATED in 1 BOTTLE
    0573-0164-301 BOTTLE in 1 CARTON > 40 TABLET, COATED in 1 BOTTLE
    0573-0164-321 BOTTLE in 1 CARTON > 50 TABLET, COATED in 1 BOTTLE
    0573-0164-331 BOTTLE in 1 CARTON > 50 TABLET, COATED in 1 BOTTLE
    0573-0164-401 BOTTLE in 1 CARTON > 80 TABLET, COATED in 1 BOTTLE
    0573-0164-411 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE
    0573-0164-431 BOTTLE in 1 CARTON > 120 TABLET, COATED in 1 BOTTLE
    0573-0164-441 BOTTLE in 1 CARTON > 140 TABLET, COATED in 1 BOTTLE
    0573-0164-461 BOTTLE in 1 CARTON > 180 TABLET, COATED in 1 BOTTLE
    0573-0164-491 BOTTLE in 1 CARTON > 200 TABLET, COATED in 1 BOTTLE
    0573-0164-5550 POUCH in 1 TRAY > 2 TABLET, COATED in 1 POUCH
    0573-0164-65120 TABLET, COATED in 1 BOTTLE
    0573-0164-913000 POUCH in 1 BOX > 2 TABLET, COATED in 1 POUCH

    * Please review the disclaimer below.