0573-0164 NDC - ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN)

Drug Information

Product NDC: 0573-0164

Proprietary Name: ADVIL PM

Non Proprietary Name: diphenhydramine citrate and ibuprofen

Active Ingredient(s):

38 mg/1 DIPHENHYDRAMINE CITRATE;
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];
Histamine H1 Receptor Antagonists [MoA];
Histamine-1 Receptor Antagonist [EPC];
Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Labeler Name:	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:	NDA021394
Marketing Category:	NDA
Start Marketing Date:	12/21/2005

Package Information

No.	Package Code	Package Description	Billing Unit
1	0573-0164-04	4 TABLET, COATED in 1 POUCH (0573-0164-04)
2	0573-0164-05	2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE	EA
3	0573-0164-08	1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL	EA
4	0573-0164-09	8 TABLET, COATED in 1 VIAL (0573-0164-09)
5	0573-0164-12	6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH	EA
6	0573-0164-14	2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH	EA
7	0573-0164-20	1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE	EA
8	0573-0164-21	1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE
9	0573-0164-30	1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE	EA
10	0573-0164-32	1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE
11	0573-0164-33	1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE
12	0573-0164-40	1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE	EA
13	0573-0164-41	1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE
14	0573-0164-43	1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE	EA
15	0573-0164-44	1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE
16	0573-0164-45	1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE
17	0573-0164-46	1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE
18	0573-0164-49	1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE
19	0573-0164-55	50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH	EA
20	0573-0164-65	120 TABLET, COATED in 1 BOTTLE (0573-0164-65)
21	0573-0164-91	3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0573-0164	The 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 NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	ADVIL PM	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	diphenhydramine citrate and ibuprofen	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, COATED	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	12/21/2005	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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.
APPLICATION NUMBER	NDA021394	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.
LABELER NAME	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	DIPHENHYDRAMINE CITRATE; IBUPROFEN	An 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 STRENGTH	38; 200
ACTIVE INGRED UNIT	mg/1; mg/1
PHARM CLASSES	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]

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

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