Drug Information

Product NDC: 43598-495

Proprietary Name: Naproxen sodium

Non Proprietary Name: Naproxen sodium

Active Ingredient(s):
  • 550 mg/1 NAPROXEN SODIUM

Administration Route(s): ORAL


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

Labeler Information

Labeler Name: Dr. Reddy's Laboratories Inc.
FDA Application Number: ANDA078486
Marketing Category: ANDA
Start Marketing Date:4/26/2016

Package Information

No. Package Code Package Description Billing Unit
143598-495-01100 TABLET, FILM COATED in 1 BOTTLE (43598-495-01)EA
243598-495-05500 TABLET, FILM COATED in 1 BOTTLE (43598-495-05)EA
343598-495-101000 TABLET, FILM COATED in 1 BOTTLE (43598-495-10)
443598-495-3030 TABLET, FILM COATED in 1 BOTTLE (43598-495-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43598-495The 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 PRESCRIPTION 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 NAMENaproxen sodiumThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMENaproxen sodiumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM 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 DATE4/26/2016This 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 NUMBERANDA078486This 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 NAMEDr. Reddy's Laboratories Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMENAPROXEN SODIUMThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 8/16/2021