Drug Information

Product NDC: 0363-0975

Proprietary Name: Naproxen Sodium

Non Proprietary Name: Naproxen Sodium

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

Administration Route(s): ORAL


Labeler Information

Labeler Name: Walgreens
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA021920
Marketing Category: NDA
Start Marketing Date:2/6/2018
End Marketing Date:12/30/2021

Package Information

No. Package Code Package Description Billing Unit
10363-0975-0880 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0975-08)
20363-0975-121 BOTTLE, PLASTIC in 1 BOX (0363-0975-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
30363-0975-18180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0975-18)
40363-0975-201 BOTTLE, PLASTIC in 1 BOX (0363-0975-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
50363-0975-401 BOTTLE, PLASTIC in 1 BOX (0363-0975-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
60363-0975-801 BOTTLE, PLASTIC in 1 BOX (0363-0975-80) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-0975The 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 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 NAMECAPSULE, LIQUID FILLEDThe 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 DATE2/6/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE12/30/2021This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NUMBERNDA021920This 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 NAMEWalgreensName 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.

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This page was last updated on: 7/26/2021