68391-050 NDC - BERKLEY AND JENSEN IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN)

Drug Information

Product NDC: 68391-050

Proprietary Name: berkley and jensen ibuprofen pm

Non Proprietary Name: diphenhydramine citrate, 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: BJWC
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA079113
Marketing Category: ANDA
Start Marketing Date:4/27/2009

Package Information

No. Package Code Package Description Billing Unit
168391-050-481 BOTTLE in 1 CARTON (68391-050-48) / 180 TABLET, COATED in 1 BOTTLE
268391-050-82200 TABLET, COATED in 1 BOTTLE (68391-050-82)

NDC Record

Field Name Field Value Definition
PRODUCT NDC68391-050The 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 NAMEberkley and jensen ibuprofen pmThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdiphenhydramine citrate, ibuprofenThe 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 DATE4/27/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA079113This 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 NAMEBJWCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDIPHENHYDRAMINE CITRATE; IBUPROFENAn 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 STRENGTH38; 200 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAnti-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