0573-0164 NDC - ADVIL PM ()

Drug Information

  • Product NDC: 0573-0164
  • Proprietary Name: Advil PM
  • Non Proprietary Name:
  • Active Ingredient(s): 38 mg/1 DIPHENHYDRAMINE CITRATE; 200 mg/1 IBUPROFEN
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Field Name Field Value
Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type:
FDA Application Number: NDA021394
Marketing Category: NDA
Start Marketing Date:12/21/2005
End Marketing Date:9/14/2018

Package Information

No. Package Code Package Description Billing Unit
10573-0164-044 TABLET, COATED in 1 POUCH (0573-0164-04)
20573-0164-052 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLEEA
30573-0164-081 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIALEA
40573-0164-098 TABLET, COATED in 1 VIAL (0573-0164-09)
50573-0164-126 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCHEA
60573-0164-142 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCHEA
70573-0164-201 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLEEA
80573-0164-211 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE
90573-0164-301 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLEEA
100573-0164-321 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE
110573-0164-331 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE
120573-0164-341 BOTTLE in 1 CARTON (0573-0164-34) / 50 TABLET, COATED in 1 BOTTLE
130573-0164-401 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLEEA
140573-0164-411 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE
150573-0164-431 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLEEA
160573-0164-441 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE
170573-0164-451 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE
180573-0164-461 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE
190573-0164-491 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE
200573-0164-5550 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCHEA
210573-0164-65120 TABLET, COATED in 1 BOTTLE (0573-0164-65)
220573-0164-913000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC0573-0164The 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.
PROPRIETARY NAMEAdvil PMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/21/2005This 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 NUMBERNDA021394This 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.
PRODUCT NDC0573-0164The 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.
PROPRIETARY NAMEADVIL PMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/21/2005This 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 NUMBERNDA021394This 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 NAMEHaleon US Holdings LLCName of Company corresponding to the labeler code segment of the Product NDC.

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

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